Malvern, PA, United States

Siemens Medical Solutions USA, Inc recalls

182 recalls recorded since 2018, most recently on 8 June 2026. 69 are listed as ongoing. Status and classification are as published by the FDA.

Recalls182

Ongoing (FDA)69

Terminated or completed113

Class I (FDA)2

Ongoing Class II Medical devices

Recall started: 8 June 2026
Reason: Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
Distribution: US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
Initiated: Voluntary: Firm initiated
Recall number: Z-2648-2026

ARTIS icono ceiling. Model Number: 11328100.

Ongoing Class II Medical devices

Recall started: 20 May 2026
Reason: Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2643-2026, Z-2641-2026, Z-2642-2026

ARTIS icono floor. Model Number: 11327700.
ARTIS icono biplane. Model Number: 11327600.
ARTIS icono ceiling. Model Number: 11328100.

Ongoing Class II Medical devices

Recall started: 12 March 2026
Reason: During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
Distribution: U.S. and O.U.S.
Initiated: FDA Mandated
Recall number: Z-1814-2026

ARTIS Pheno VE30A and VE40A, Model 10849000

Ongoing Class II Medical devices

Recall started: 10 March 2026
Reason: During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
Distribution: Worldwide - US Nationwide distribution.
Initiated: FDA Mandated
Recall number: Z-1653-2026

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

Ongoing Class II Medical devices

Recall started: 9 March 2026
Reason: During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
Distribution: US and Worldwide
Initiated: FDA Mandated
Recall numbers: Z-2206-2026, Z-2205-2026

ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

Ongoing Class II Medical devices

Recall started: 29 December 2025
Reason: Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Distribution: Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1174-2026, Z-1175-2026

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02

Ongoing Class II Medical devices

Recall started: 19 December 2025
Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1242-2026, Z-1239-2026, Z-1240-2026, Z-1241-2026

NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Ongoing Class II Medical devices

Recall started: 5 December 2025
Reason: A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.
Distribution: U.S. and OUS
Initiated: FDA Mandated
Recall number: Z-0999-2026

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

Ongoing Class II Medical devices

Recall started: 24 October 2025
Reason: There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Distribution: Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0878-2026, Z-0879-2026, Z-0877-2026

MAMMOMAT Inspiration;
MAMMOMAT Fusion;
MAMMOMAT Revelation;

Ongoing Class I Medical devices

Recall started: 1 October 2025
Reason: There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Distribution: US distribution to California. International distribution to Australia, Germany, Great Britian.
Initiated: Voluntary: Firm initiated
Recall number: Z-0431-2026

MAGNETOM Cima.X Upgrade. Model Number: 11689304.

Ongoing Class I Medical devices

Recall started: 28 August 2025
Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Distribution: Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyp
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2660-2025, Z-2654-2025, Z-2664-2025, Z-2658-2025, Z-2663-2025, Z-2662-2025, Z-2667-2025, Z-2668-2025, Z-2661-2025, Z-2656-2025, Z-2666-2025, Z-2657-2025 and 3 more

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
Biograph mMR. Model Number: 10433372.
MAGNETOM Verio. Model Number: 10276755.
MAGNETOM Lumina (DE). Model Number: 11344916.
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
MAGNETOM Vida Fit. Model Number: 11410481.
and 7 more product lines

Ongoing Class II Medical devices

Recall started: 12 August 2025
Reason: Limited system movements after startup .
Distribution: US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.
Initiated: Voluntary: Firm initiated
Recall number: Z-2529-2025

Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

Ongoing Class II Medical devices

Recall started: 4 June 2025
Reason: A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Distribution: Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1982-2025, Z-1981-2025

UROSKOP Omnia Max. Model Number: 10762473
UROSKOP Omnia. Model Number: 10094910

Ongoing Class II Medical devices

Recall started: 15 May 2025
Reason: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Distribution: Worldwide.
Initiated: FDA Mandated
Recall numbers: Z-2020-2025, Z-2021-2025, Z-2022-2025, Z-2019-2025

interventional fluoroscopic x-ray system
interventional fluoroscopic x-ray system
interventional fluoroscopic x-ray system
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be p

Ongoing Class II Medical devices

Recall started: 2 January 2025
Reason: A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
Distribution: 23 Distributed in the US
Recall number: Z-0922-2025

ARTIS One Angiographic X-Ray System

Ongoing Class II Medical devices

Recall started: 15 August 2024
Reason: If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
Distribution: US: MS, WA, TX, NJ, GA, PN, NY, AL, MN, NE, IN, CT, CA, IL, TN, WI, ND, NM, AR, NC, PR, RI, WY, MD, FL, HI, AZ, SC, MO, OK, VA, ME, KS, MI, LA, IA, OH, SD, NH, KY, AL, OR, MA, GU. OUS: Afghanistan, Albania, Algeria, Andorra, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangl
Initiated: Voluntary: Firm initiated
Recall numbers: Z-3215-2024, Z-3217-2024, Z-3216-2024

ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software

Ongoing Class II Medical devices

Recall started: 3 July 2024
Reason: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Distribution: US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2438-2024, Z-2439-2024, Z-2440-2024, Z-2441-2024

Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology stu
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electroph
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or el
Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional

Ongoing Class II Medical devices

Recall started: 2 July 2024
Reason: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2527-2024, Z-2525-2024, Z-2526-2024, Z-2528-2024

LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700

Ongoing Class II Medical devices

Recall started: 31 May 2024
Reason: Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2184-2024, Z-2186-2024, Z-2183-2024, Z-2187-2024, Z-2182-2024, Z-2185-2024, Z-2181-2024, Z-2180-2024, Z-2188-2024

AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number:475517
AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395431
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 475525
AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395381
AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395415
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399
and 1 more product lines

Ongoing Class II Medical devices

Recall started: 21 March 2024
Reason: Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1598-2024

Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Arti

Ongoing Class II Medical devices

Recall started: 23 February 2024
Reason: On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
Distribution: Worldwide distribution - US Nationwide including in the states of AL, AR, CA, CO , CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA , MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WY and the countries of BG, BW, BA, TR, AR, CL, CN, FR, SK, CD, BH, PH, AM,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1600-2024, Z-1601-2024, Z-1599-2024

ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A,

Ongoing Class II Medical devices

Recall started: 29 November 2023
Reason: The possibility of the Sensis documentation functionality application to crash.
Distribution: Domestic: CA, CT, & FL.
Initiated: Voluntary: Firm initiated
Recall number: Z-0683-2024

Sensis Vibe Hemo

Ongoing Class II Medical devices

Recall started: 17 October 2023
Reason: Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
Distribution: US Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United Kingdom Israel Netherlands Sweden South Africa
Initiated: Voluntary: Firm initiated
Recall number: Z-0523-2024

ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100

Ongoing Class II Medical devices

Recall started: 5 October 2023
Reason: Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure LED light) the operator can monitor the x ray release. Also, after a successful x ray exposure, the clinical image is displayed on the monitor.
Distribution: US Nationwide - Worldwide
Initiated: FDA Mandated
Recall number: Z-0223-2024

Mobilett Mira wireless (VA20) mobile x-ray system(s)

Ongoing Class II Medical devices

Recall started: 12 September 2023
Reason: Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0196-2024, Z-0195-2024

***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200

Ongoing Class II Medical devices

Recall started: 1 September 2023
Reason: In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential artifacts depend on the position of the headband, the amount of lubricating grease, as well as the sequence parameters used
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-2648-2023

(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used with the following MAGNETOM MRI Systems: MA

Ongoing Class II Medical devices

Recall started: 13 July 2023
Reason: If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way.
Distribution: Worldwide - US Nationwide distribution including in the states of IL, WI, CA, NM, TX, NC, MI, MD, NY, OH, IN, NE, PA, LA, SC, MO, OK, VA, ME, AZ, PR, IA, NH, NJ, AR, FL, SD and the countries of GR, ES, SG, TH, KR, IN, DE, TR, AT, IT, AU, JP, FR, CA, PT, SK, BR, SA, GB, NZ, RO, SE, AE, CN, HR, PL, CH
Initiated: Voluntary: Firm initiated
Recall number: Z-2582-2023

ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

Ongoing Class II Medical devices

Recall started: 12 July 2023
Reason: During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.
Distribution: Distribution was made to ID, KS, MA, NH, OH, TX, and VA. There was no government/military distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Canada, Colombia, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Portugal, Singapore, S
Initiated: Voluntary: Firm initiated
Recall number: Z-2256-2023

The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752;

Ongoing Class II Medical devices

Recall started: 19 June 2023
Reason: Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Latvia, Luxembourg, Macedonia, Mexico, Monaco, Netherlands, New Zealand, Norway
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2361-2023, Z-2360-2023, Z-2359-2023

ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700
ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600

Ongoing Class II Medical devices

Recall started: 5 June 2023
Reason: Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk of electric shock exists (e.g., ingress of a large amount of liquid following the plexiglass dropping off, at the same time the user or operator happens to touch the liquid on the cover which is connected to the internal live parts).
Distribution: Worldwide - US Nationwide distribution in the states of FL, GA, KS, MN, NC, NY and the countries of Austria, Bangladesh, Brazil, Canada, China, Croatia, El Salvador, France, Germany, Indonesia, Italy, Japan, Jordan, Lebanon, Luxembourg, Mauritius, Mexico, Monaco, Peru, Philippines, Poland, Romania
Initiated: Voluntary: Firm initiated
Recall number: Z-2240-2023

Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088

Ongoing Class II Medical devices

Recall started: 21 March 2023
Reason: Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
Distribution: Worldwide - US Nationwide distribution in the states of FL, SD, PR and the countries of Angola, Argentina, Australia, Brazil, Bulgaria, China, Georgia, Germany, India, Indonesia, Iraq, Japan, Malaysia, Morocco, Nepal, Nigeria, Poland, Russia, Rwanda, Serbia, Slovenia, South Africa, Spain, Sudan, S
Initiated: Voluntary: Firm initiated
Recall number: Z-1469-2023

ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600

Ongoing Class II Medical devices

Recall started: 2 February 2023
Reason: In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1311-2023

ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

Ongoing Class II Medical devices

Recall started: 2 February 2023
Reason: If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message Endposition reached will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen Live images may not match the previously stored reference images. Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1498-2023

ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000

Ongoing Class II Medical devices

Recall started: 16 January 2023
Reason: This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
Distribution: Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1135-2023, Z-1136-2023, Z-1134-2023

SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission

Ongoing Class II Medical devices

Recall started: 22 December 2022
Reason: In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-1003-2023

Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM g

Ongoing Class II Medical devices

Recall started: 21 December 2022
Reason: Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1167-2023, Z-1165-2023, Z-1168-2023, Z-1164-2023, Z-1166-2023

Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200

Ongoing Class II Medical devices

Recall started: 16 December 2022
Reason: Mechanical connection between the tabletop and table base may be lost.
Distribution: Worldwide distribution - US Nationwide and the countries of Armenia, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Italy, Japan, Kazakhstan, Kuwait, Lebanon, Monaco,
Initiated: Voluntary: Firm initiated
Recall number: Z-0956-2023

ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

Ongoing Class II Medical devices

Recall started: 16 December 2022
Reason: In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1040-2023

System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q bip

Ongoing Class II Medical devices

Recall started: 9 December 2022
Reason: There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.
Distribution: Worldwide distribution
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1002-2023, Z-1001-2023, Z-1000-2023

Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
AXIOM Luminos Agile
AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF

Ongoing Class II Medical devices

Recall started: 23 November 2022
Reason: Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.
Distribution: US Nationwide - Worldwide Distribution
Initiated: FDA Mandated
Recall numbers: Z-1479-2023, Z-1480-2023, Z-1481-2023

Luminos Agile Max (VE10, VF10, VF11)
Luminos dRF Max (VE10, VF10, VF11)
LUMINOS Lotus Max (VF11)

Ongoing Class II Medical devices

Recall started: 16 November 2022
Reason: The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE CORRUPTED" error message during system boot; 2) Subsystem crash during examination; 3) Dialog Monitor Computer (DMC) application crash while loading a study; and 4) Software crash due to system internal timeout. Issue 1 may lead to a delay or interruption of procedure. Issues 2, 3, and 4 may result in delay in starting or continuing the examination, and may also prevent the operator from starting or continuing a study;
Distribution: Domestic distribution nationwide. Worldwide foreign distribution to Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belgium Bolivia Bosnia and Herzegovina Botswana Bulgaria Cambodia Canada Chile China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark
Initiated: Voluntary: Firm initiated
Recall number: Z-0775-2023

Programmable Diagnostic Computer

Ongoing Class II Medical devices

Recall started: 9 November 2022
Reason: When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
Distribution: US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.
Initiated: Voluntary: Firm initiated
Recall number: Z-0472-2023

ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for

Ongoing Class II Medical devices

Recall started: 20 September 2022
Reason: Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
Initiated: Voluntary: Firm initiated
Recall number: Z-0119-2023

ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000

Ongoing Class II Medical devices

Recall started: 10 August 2022
Reason: Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
Distribution: Worldwide Distribution: US (nationwide) and OUS (Foreign) to countries of: United Arab Emirates; Armenia; Angola; Argentina; Austria; Australia; Bangladesh; Belgium; Bulgaria; Bahrain; Brazil; Canada; Switzerland; China; Colombia; Costa Rica; Czech Republic; Germany; Denmark; Dominican Republic; Alg
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1647-2022, Z-1645-2022, Z-1646-2022

Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 108483
Artis pheno- Model No. 10849000

Terminated Class III Medical devices

Recall started: 12 July 2022
Terminated: 7 November 2024
Reason: The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table), In the event the mounting position deviates from the default position, the following are possible: Patient touching the Signal Input Box may result in a touch leakage current to the patient; Spillage of liquid entering the Signal Input Box
Distribution: US Nationwide Distribution Foreign: Albania Algeria Angola Argentina Armenia Aruba Australia Austria Azerbaijan Bahrain Bangladesh Belgium Bolivia Bosnia and Herzegovina Brunei Darussalam Bulgaria Cambodia Cameroon Canada Chile China Colombia Costa Rica Croatia Cuba Cypru
Initiated: Voluntary: Firm initiated
Recall number: Z-1558-2022

AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP

Ongoing Class II Medical devices

Recall started: 15 June 2022
Reason: Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting in no vital signs being available.
Distribution: US Nationwide Distribution AZ FL KY MI OH PR TX
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1425-2022, Z-1426-2022

Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 1100

Ongoing Class II Medical devices

Recall started: 10 June 2022
Reason: A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.
Distribution: Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Brazil Canada China Colombia Denmark Finland France Germany Hungary Indonesia Iran Italy Japan Kuwait Mexico Monaco Netherlands Norway Poland Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand T
Initiated: Voluntary: Firm initiated
Recall number: Z-1294-2022

Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000

Terminated Class II Medical devices

Recall started: 24 May 2022
Terminated: 22 January 2025
Reason: It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only be reactivated by a field service engineer.
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CO, FL, IL, LA, ME, MN, MO, NC, OH, PA, SC, TN, TX, WI and the countries of Australia, Austria, Azerbaijan, Belgium, Canada, China, Finland, France, Germany, Hong Kong, India, Italy, Japan, Lebanon, Lithuania, Luxemb
Initiated: Voluntary: Firm initiated
Recall number: Z-1343-2022

Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System

Ongoing Class II Medical devices

Recall started: 20 May 2022
Reason: During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
Distribution: Domestic distribution to AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WI and the countries of Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Jap
Initiated: Voluntary: Firm initiated
Recall number: Z-1342-2022

Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

Ongoing Class II Medical devices

Recall started: 13 April 2022
Reason: Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
Distribution: Domestic distribution nationwide.
Initiated: Voluntary: Firm initiated
Recall number: Z-1243-2022

Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620

Ongoing Class II Medical devices

Recall started: 11 April 2022
Reason: if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1245-2022, Z-1246-2022

Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700

Terminated Class II Medical devices

Recall started: 11 March 2022
Terminated: 14 April 2023
Reason: There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
Distribution: Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.
Initiated: Voluntary: Firm initiated
Recall number: Z-0893-2022

Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems

Ongoing Class II Medical devices

Recall started: 7 March 2022
Reason: Transducers (component of ultrasound system) may exceed recommended thermal index limits
Distribution: Worldwide distribution - US Nationwide distribution in the states of Washington, Alaska, Ohio, South Carolina, Pennsylvania, Arizona, New York, Texas and the countries of Australia, Czech Republic, France, United Kingdom, Indonesia, Mexico, New Zealand.
Initiated: Voluntary: Firm initiated
Recall number: Z-1010-2022

Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,

Ongoing Class II Medical devices

Recall started: 7 March 2022
Reason: Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-0962-2022

SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM g

Terminated Class II Medical devices

Recall started: 7 March 2022
Terminated: 19 December 2023
Reason: Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0995-2022, Z-0994-2022, Z-0996-2022, Z-0997-2022

syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

Ongoing Class II Medical devices

Recall started: 7 March 2022
Reason: For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray collimator is automatically positioned in a way that the subsequent series of acquisition covers the defined field of view needed for each step. However, during the acquisition the collimation area displayed to the operator on the User Interface does not correctly represent the collimation area specified by the system. It indicates to the user an open collimator instead, e.g., the information displayed on the User Interface shows wider area of collimation than values preset prior to the examination. However, the collimation of the x-ray is performed correctly and always matches the examination area predefined by the user.
Distribution: US Nationwide, Worldwide distribution
Initiated: FDA Mandated
Recall number: Z-0730-2022

YSIO X.Pree

Ongoing Class II Medical devices

Recall started: 25 February 2022
Reason: Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0986-2022, Z-0985-2022, Z-0987-2022

Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000

Ongoing Class II Medical devices

Recall started: 25 February 2022
Reason: After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.
Distribution: US Nationwide.
Initiated: Voluntary: Firm initiated
Recall number: Z-1339-2022

syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) A

Ongoing Class II Medical devices

Recall started: 23 February 2022
Reason: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
Distribution: US Nationwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0971-2022, Z-0975-2022, Z-0977-2022, Z-0978-2022, Z-0970-2022, Z-0969-2022, Z-0972-2022, Z-0974-2022, Z-0968-2022, Z-0980-2022, Z-0976-2022, Z-0979-2022 and 2 more

Artis zee floor MN, Model Number 10094142
Artis Q ceiling, Model Number 10848281
Artis Q zeego, Model Number 10848283
Artis Q.zen floor, Model Number 10848353
Artis zee biplane, Model Number 10094141
Artis zee multi-purpose, Model Number 10094139
Artis zee biplane MN, Model Number 10094143
Artis Q floor, Model Number 10848280
and 6 more product lines

Ongoing Class II Medical devices

Recall started: 31 January 2022
Reason: Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.
Distribution: US Nationwide.
Initiated: Voluntary: Firm initiated
Recall number: Z-0841-2022

Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system

Ongoing Class II Medical devices

Recall started: 19 January 2022
Reason: The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.
Distribution: Worldwide distribution: US (nationwide) and countries of: Algeria, Andorra, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Faroe Islands, France, Germany,
Initiated: Voluntary: Firm initiated
Recall number: Z-0748-2022

Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, P

Terminated Class II Medical devices

Recall started: 9 December 2021
Terminated: 4 May 2023
Reason: Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
Distribution: US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.
Initiated: Voluntary: Firm initiated
Recall number: Z-0441-2022

ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815

Ongoing Class II Medical devices

Recall started: 23 November 2021
Reason: Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible.
Distribution: US Nationwide distribution in the states of AK, AL, AR, AZ, CA, FL, GU, HI, IA, IL, IN, KS, KY, MA, MI, MO, MS, NC, NE, NJ, NY, OH, OK,PA, PR, SD, TN, TX, WA, WV.
Initiated: Voluntary: Firm initiated
Recall number: Z-0499-2022

1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is

Ongoing Class II Medical devices

Recall started: 19 November 2021
Reason: Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0474-2022, Z-0473-2022, Z-0475-2022, Z-0472-2022

SOMATOM Edge Plus-Computed tomography system Model 1026700
SOMATOM Definition AS-Computed tomography system Model 8098027
SOMATOM Definition Edge -Computed tomography system Model 10590000
SOMATOM Confidence -Computed tomography systems Model 10590100

Ongoing Class II Medical devices

Recall started: 12 November 2021
Reason: Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CN, DE, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY. The countries of United Arab Emirate
Initiated: Voluntary: Firm initiated
Recall number: Z-0547-2022

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

Terminated Class II Medical devices

Recall started: 20 October 2021
Terminated: 18 June 2024
Reason: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0304-2022, Z-0300-2022, Z-0302-2022, Z-0296-2022, Z-0297-2022, Z-0305-2022, Z-0299-2022, Z-0301-2022, Z-0303-2022, Z-0298-2022

Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141
Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281
and 2 more product lines

Terminated Class II Medical devices

Recall started: 12 October 2021
Terminated: 11 April 2024
Reason: Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0515-2022, Z-0516-2022, Z-0517-2022

Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700

Ongoing Class II Medical devices

Recall started: 5 October 2021
Reason: System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-0226-2022

Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supportin

Ongoing Class II Medical devices

Recall started: 24 September 2021
Reason: Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-0200-2022

Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplac

Terminated Class II Medical devices

Recall started: 30 August 2021
Terminated: 16 January 2024
Reason: software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0285-2022, Z-0284-2022, Z-0283-2022, Z-0286-2022, Z-0288-2022, Z-0287-2022, Z-0289-2022

SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
SOMATOM Force with software syngo.CT VB20 Model #10742326
SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
SOMATOM Confidence with software syngo.CT VB20 Model #10590100
SOMATOM Drive with software syngo.CT VB20 Model #10431700
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

Ongoing Class II Medical devices

Recall started: 18 August 2021
Reason: Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in diagnosis or scan aborts with the necessity for patient rescan may occur
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-2500-2021

Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.A

Ongoing Class II Medical devices

Recall started: 16 August 2021
Reason: Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2446-2021, Z-2445-2021, Z-2447-2021

syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers:
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815

Terminated Class II Medical devices

Recall started: 12 July 2021
Terminated: 16 October 2024
Reason: Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
Distribution: Worldwide distribution - U.S. Nationwide distribution in the Puerto Rico and the countries of Bosnia Herzegovina, Canada, Colombia, Germany, Greece, Italy, North Macedonia, Poland, and Slovenia.
Initiated: Voluntary: Firm initiated
Recall number: Z-2471-2021

ACUSON Juniper Diagnostic Ultrasound System

Terminated Class II Medical devices

Recall started: 30 June 2021
Terminated: 10 February 2023
Reason: Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment
Distribution: US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, ND, NE, NH, NJ, NV, NY, OH, PA, TN, TX, UT, VA, WA, WI.
Initiated: Voluntary: Firm initiated
Recall number: Z-2404-2021

Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen

Ongoing Class II Medical devices

Recall started: 27 May 2021
Reason: Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system
Distribution: US Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-2029-2021

ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000

Terminated Class II Medical devices

Recall started: 20 April 2021
Terminated: 8 November 2023
Reason: Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not hit the detector. This may only occur when an organ program for the wall mode without top alignment is selected and the system is moved to the centred position. If afterwards the operator activates the top alignment, increases the collimation, and lifts the tube, the system allows examination even with the tube being misaligned to the detector position. Hence, it is possible to overshoot the detector by more than 20%. From a clinical point of view, it is highly unlikely for the operator to trigger the examination as the misalignment is visible due to the light field being out of range. AND In very rare cases it may occur that the calculated dose value exceeds the limit of 2 Gy. This may potentially occur only when an organ program for free exposure is selected, and the system uses incorrect (too small) source-to-image distance (SID) for calculating applied dose. Hence, the calculated dose is much higher than the actual applied dose causing the buzzer, which normally notifies the operator about the exceeded limit of 2 Gy, to get activated erroneously.
Distribution: US Nationwide distribution
Initiated: FDA Mandated
Recall number: Z-1685-2021

Multitom RAX with software version VF10

Terminated Class II Medical devices

Recall started: 30 March 2021
Terminated: 12 July 2022
Reason: Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the belts which may result in limited functionality of the Artis system up to system failure. Unintended movement of the C-Arm may cause a hazardous situation to the patient, operator, or staff members and may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1496-2021

Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System

Ongoing Class II Medical devices

Recall started: 26 March 2021
Reason: Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-1495-2021

Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137

Terminated Class II Medical devices

Recall started: 19 March 2021
Terminated: 9 November 2021
Reason: Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.
Distribution: Worldwide distribution: US (nationwide) including states of: CA, CO, DE, FL, IL, IN, KY, MD, MI, NC, NE, NJ, NY, OH, TN, TX, UT, WI, and OUS (countries) of: AT, BE, ES, IT, FI, CH, FR, GB, SE, DE, DK, IE and NL.
Initiated: Voluntary: Firm initiated
Recall number: Z-1497-2021

Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnosti

Terminated Class II Medical devices

Recall started: 10 March 2021
Terminated: 11 December 2023
Reason: A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead of the currently acquired image, previously acquired image (potentially image of the previous patient) may be displayed to the user, potentially impact diagnosis of the patient examined when the connection was interrupted
Distribution: US Nationwide distribution in the states of FL, MN, OH, PA, TX.
Initiated: Voluntary: Firm initiated
Recall number: Z-1346-2021

Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.

Terminated Class II Medical devices

Recall started: 4 March 2021
Terminated: 30 September 2024
Reason: Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or Denial of Service attacks and could result in incorrect diagnostic or therapeutic decisions
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1434-2021

Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 1091

Terminated Class II Medical devices

Recall started: 3 March 2021
Terminated: 28 December 2023
Reason: SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1253-2021

Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SO

Terminated Class II Medical devices

Recall started: 26 February 2021
Terminated: 11 August 2021
Reason: Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.
Distribution: US Nationwide distribution in the states of MI, KY, TX.
Initiated: Voluntary: Firm initiated
Recall number: Z-1288-2021

Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Ongoing Class II Medical devices

Recall started: 4 February 2021
Reason: The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births.
Distribution: U.S.: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY O.U.S.: U.A.E., Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Ric
Initiated: Voluntary: Firm initiated
Recall number: Z-1330-2021

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

Terminated Class II Medical devices

Recall started: 27 January 2021
Terminated: 25 October 2021
Reason: System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
Distribution: US Nationwide distribution in the states of AK, AR, CA, GU, IA, IL, MI, MO, NC, NE, OR, PA, PA, PR, SD, TN, TX, WA.
Initiated: Voluntary: Firm initiated
Recall number: Z-1173-2021

Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Se

Terminated Class II Medical devices

Recall started: 18 December 2020
Terminated: 17 November 2021
Reason: Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures to be terminated and performed on an alternative x-ray system
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1144-2021

ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.

Ongoing Class II Medical devices

Recall started: 30 November 2020
Reason: When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.
Distribution: Worldwide-US Nationwide
Initiated: FDA Mandated
Recall number: Z-0656-2021

Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

Terminated Class II Medical devices

Recall started: 24 November 2020
Terminated: 6 February 2024
Reason: System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan
Distribution: US Nationwide
Initiated: FDA Mandated
Recall number: Z-0771-2021

SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus

Terminated Class II Medical devices

Recall started: 21 October 2020
Terminated: 5 May 2021
Reason: Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AR, CA, IA, IL and the countries of China, Germany, India, Indonesia, Italy, Japan, Philippines, Saudi Arabia, South Korea, Taiwan, Turkey, and United Kingdom.
Initiated: Voluntary: Firm initiated
Recall number: Z-0469-2021

Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography syst

Terminated Class II Medical devices

Recall started: 21 September 2020
Terminated: 3 August 2021
Reason: Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).
Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, IN, LA, MI, MO, NC, NJ, NY, PA, TX, WA.
Initiated: Voluntary: Firm initiated
Recall number: Z-0298-2021

Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and in

Terminated Class II Medical devices

Recall started: 18 September 2020
Terminated: 23 July 2021
Reason: There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been started while the C-Arm or table is moving, there may be a shift between the image acquired at the start position and the image (i.e. DSA vessel map) taken at the reference position. This may lead to a DSA vessel map being overlaid to a subtracted fluoro image at a position that is not accurate.. However, if the displacement is slight or at an unfavorable plane, the user might rely on incorrect visualization of the catheter relative to the vessel map. This could imply danger to the patient.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-0400-2021

ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures inc

Terminated Class II Medical devices

Recall started: 9 September 2020
Terminated: 16 April 2021
Reason: After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0805-2021, Z-0806-2021

Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery

Terminated Class II Medical devices

Recall started: 19 August 2020
Terminated: 19 April 2023
Reason: Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-3005-2020

Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180

Terminated Class II Medical devices

Recall started: 14 August 2020
Terminated: 1 May 2023
Reason: This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential risk.
Distribution: US Nationwide distribution including in the states of Alabama, Alaska, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Car
Initiated: Voluntary: Firm initiated
Recall number: Z-2934-2020

Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole bo

Terminated Class II Medical devices

Recall started: 3 August 2020
Terminated: 3 February 2021
Reason: Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical procedure
Distribution: US Natonwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-0108-2021

Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 A

Terminated Class II Medical devices

Recall started: 30 July 2020
Terminated: 20 May 2021
Reason: Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
Distribution: US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2888-2020, Z-2887-2020

Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

Terminated Class II Medical devices

Recall started: 24 July 2020
Terminated: 2 November 2021
Reason: The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditions, the HemoBox may stop functioning and all vital signs are lost
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-2921-2020

Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interven

Terminated Class II Medical devices

Recall started: 14 July 2020
Terminated: 23 July 2021
Reason: Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging functionality.
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-2848-2020

Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical stru

Terminated Class II Medical devices

Recall started: 24 June 2020
Terminated: 5 April 2023
Reason: If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in Synthetic CT , the software does not recognize the adapted acquisition plane. This may result in images with wrong geometry. When this distortion remains unnoticed and the images are subsequently exported to a treatment planning system (TPS), an incorrect calculated radiation treatment plan cannot be excluded. The occurence of this issue is very unlikely and has never been reported so far.
Distribution: US Nationwide distribution including in the states of AZ, MA, WI, FL, PA. TX, MD, LA, TX, MN, MI, NY, SC, OH, GA, CA, IL, MO, CA, TX.
Initiated: Voluntary: Firm initiated
Recall number: Z-2688-2020

syngo.via RT Image Suite with software versions syngo.via VB30 or VB40

Terminated Class II Medical devices

Recall started: 22 June 2020
Terminated: 9 March 2021
Reason: Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-3025-2020

Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #

Terminated Class II Medical devices

Recall started: 22 May 2020
Terminated: 15 October 2021
Reason: Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
Distribution: U.S.: AZ, CA, FL, GA, IL, KY, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TX, VA, WA and WV. O.U.S; Canada
Initiated: Voluntary: Firm initiated
Recall number: Z-0090-2021

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F

Terminated Class II Medical devices

Recall started: 7 May 2020
Terminated: 29 September 2022
Reason: If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6 deg. This limitation may lead to difficulties in removing the vacuum biopsy system.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-2388-2020

MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.

Terminated Class II Medical devices

Recall started: 30 April 2020
Terminated: 11 September 2020
Reason: Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned procedures to be terminated and performed on an alternative x-ray system
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-2302-2020

Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis ze

Terminated Class II Medical devices

Recall started: 23 April 2020
Terminated: 26 October 2020
Reason: Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient
Distribution: AZ, IL, UT, WI
Initiated: Voluntary: Firm initiated
Recall number: Z-2257-2020

ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

Terminated Class II Medical devices

Recall started: 22 April 2020
Terminated: 9 October 2020
Reason: If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be reached. In the event the C-arms movements are not possible, the system can only be returned to normal operation with the support of a field service engineer
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-2108-2020

ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures incl

Terminated Class II Medical devices

Recall started: 20 April 2020
Terminated: 10 May 2021
Reason: Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector
Distribution: US Nationwide distributions.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1958-2020, Z-1957-2020, Z-1959-2020

Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applicat
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applicati
Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during cl

Terminated Class II Medical devices

Recall started: 17 April 2020
Terminated: 25 August 2020
Reason: The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.
Distribution: US Nationwide Distribution to states of: AR, AZ, CA, FL, IL, IN, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OH, OK, SC, TN, TX, UT, VA, WA, and Puerto Rico.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2128-2020, Z-2127-2020

Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structur

Terminated Class II Medical devices

Recall started: 6 April 2020
Terminated: 27 October 2020
Reason: It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be released for less than 500ms, therefore, the overall dose is estimated at 0.01mSv or less than 500 mGy in total.
Distribution: Worldwide Distribution
Initiated: FDA Mandated
Recall numbers: Z-1764-2020, Z-1765-2020

System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiograph
System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems; and allows radiographic exposures of

Terminated Class II Medical devices

Recall started: 18 February 2020
Terminated: 9 February 2021
Reason: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Distribution: Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pen
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1678-2020, Z-1679-2020, Z-1677-2020, Z-1680-2020

MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINA
ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

Terminated Class II Medical devices

Recall started: 14 February 2020
Terminated: 20 April 2021
Reason: A software issue could potentially cause the stand and table movements to be blocked.
Distribution: US Nationwide distribuiton.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1496-2020, Z-1495-2020, Z-1497-2020

Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems develope
Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems dev

Terminated Class II Medical devices

Recall started: 10 February 2020
Terminated: 31 August 2020
Reason: The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement.
Distribution: US Nationwide distribution in the states of AR, CA, DC, FL, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TX, UT, VA and WI.
Initiated: Voluntary: Firm initiated
Recall number: Z-1501-2020

Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.

Terminated Class II Medical devices

Recall started: 24 January 2020
Terminated: 10 July 2020
Reason: Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1340-2020

ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional

Terminated Class II Medical devices

Recall started: 16 January 2020
Terminated: 4 January 2021
Reason: A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the patient and dose to wrong location.
Distribution: Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1346-2020

COHERENCE Oncologist, Model Nos. 07333680 & 07351898

Terminated Class II Medical devices

Recall started: 8 January 2020
Terminated: 21 June 2022
Reason: A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1339-2020, Z-1338-2020, Z-1337-2020

Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: s
Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ra
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications rangin

Terminated Class II Medical devices

Recall started: 8 January 2020
Terminated: 21 June 2022
Reason: Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1332-2020, Z-1331-2020, Z-1333-2020

Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ra
Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications rangin
Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for ur

Terminated Class II Medical devices

Recall started: 8 January 2020
Terminated: 21 June 2022
Reason: Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2757-2020, Z-2758-2020, Z-2756-2020, Z-2755-2020

SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

Terminated Class II Medical devices

Recall started: 20 December 2019
Terminated: 1 May 2020
Reason: The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.
Initiated: Voluntary: Firm initiated
Recall number: Z-0807-2020

Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to,

Terminated Class II Medical devices

Recall started: 25 November 2019
Terminated: 6 May 2020
Reason: During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.
Distribution: US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
Initiated: Voluntary: Firm initiated
Recall number: Z-0782-2020

Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application

Terminated Class II Medical devices

Recall started: 14 November 2019
Terminated: 12 May 2020
Reason: In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or interruption of a procedure.
Distribution: US: WA and TX International: Denmark
Initiated: Voluntary: Firm initiated
Recall number: Z-0695-2020

Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C

Terminated Class II Medical devices

Recall started: 7 October 2019
Terminated: 14 November 2022
Reason: Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-0406-2020

Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definit

Terminated Class II Medical devices

Recall started: 24 September 2019
Terminated: 8 July 2024
Reason: SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures
Distribution: US in the states of: GA, IN, MO, MS, NJ, OH, PA
Initiated: Voluntary: Firm initiated
Recall number: Z-0265-2020

SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system

Terminated Class II Medical devices

Recall started: 31 July 2019
Terminated: 2 December 2020
Reason: The injector holder could potentially fall off together with the injector and the storage box.
Distribution: US Nationwide Distribution in the states FL KS WI NE MS OH TX NY LA IN IL OK MI GA NJ AK CT AL MD
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2404-2019, Z-2405-2019, Z-2399-2019, Z-2403-2019, Z-2400-2019, Z-2401-2019, Z-2402-2019

SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission dat
SOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
SOMATOM go.All; Models #11061630 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data

Terminated Class II Medical devices

Recall started: 30 July 2019
Terminated: 29 April 2020
Reason: Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations for patients and medical personnel due to falling parts
Distribution: US Nationwide Distribution - AL, AR, KS, MI, MN, NC, ND, NY, OH, SC, TX, WI
Initiated: Voluntary: Firm initiated
Recall number: Z-2367-2019

Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Art

Terminated Class II Medical devices

Recall started: 25 July 2019
Terminated: 29 December 2022
Reason: SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans
Distribution: Nationwide Foreign:
Initiated: Voluntary: Firm initiated
Recall number: Z-2440-2019

syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603

Terminated Class II Medical devices

Recall started: 23 July 2019
Terminated: 6 May 2020
Reason: An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-0160-2020

Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures

Terminated Class II Medical devices

Recall started: 10 July 2019
Terminated: 3 June 2020
Reason: Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
Distribution: State WV NY PA FL OK FL NJ NY IL WY NY GA NY PA PA AL NJ NY ***updated 8/14/19*** OH NC
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2197-2019, Z-2196-2019, Z-2195-2019, Z-2198-2019

Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a
Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting
Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting
Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecti

Terminated Class II Medical devices

Recall started: 9 July 2019
Terminated: 23 April 2020
Reason: Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
Distribution: AL AR AZ CA CO CT DC DE FL GA GU IA ID IL IN KS KY LA MA MD ME MI MN MO MT NC NE NH NJ NY OH OK OR PA SC TN TX VA WA WI WV WY
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2344-2019, Z-2345-2019, Z-2343-2019, Z-2342-2019

MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643
MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914

Terminated Class II Medical devices

Recall started: 3 July 2019
Terminated: 10 May 2024
Reason: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2268-2019, Z-2271-2019, Z-2274-2019, Z-2273-2019, Z-2269-2019, Z-2270-2019, Z-2272-2019

SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The imag
SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images deli
SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images deli
SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images
SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The i
SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The
SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images

Terminated Class II Medical devices

Recall started: 20 June 2019
Terminated: 17 April 2020
Reason: DAP chamber may be missing an insulating foil
Distribution: IL, NE
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1954-2019, Z-1953-2019

Cios care fusion system
Cios Alpha VA20/ VA30 mobile X-Ray systems

Terminated Class II Medical devices

Recall started: 12 June 2019
Terminated: 18 September 2020
Reason: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2021-2019, Z-2013-2019, Z-2032-2019, Z-2023-2019, Z-2027-2019, Z-2029-2019, Z-2022-2019, Z-2024-2019, Z-2028-2019, Z-2019-2019, Z-2031-2019, Z-2034-2019 and 11 more

AXIOM Artis dTC, Model Number 7413078
AXIOM Artis FA, Model Number 5904441
Artis zee floor MN, Model Number 10094142
AXIOM Artis dMP, Model Number 7555365
AXIOM Artis dBC, Model Number 7728392
Artis zee ceiling, Model Number 10094137
AXIOM Artis dBA, Model Number 7555357
AXIOM Artis dFA, Model Number 7555373
and 15 more product lines

Terminated Class II Medical devices

Recall started: 6 June 2019
Terminated: 9 February 2021
Reason: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1894-2019, Z-1901-2019, Z-1898-2019, Z-1899-2019, Z-1896-2019, Z-1895-2019, Z-1903-2019, Z-1900-2019, Z-1902-2019, Z-1905-2019, Z-1904-2019, Z-1897-2019

Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283
Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280
Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281
Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141
Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137
Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
and 4 more product lines

Terminated Class II Medical devices

Recall started: 4 June 2019
Terminated: 29 March 2023
Reason: The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
Distribution: US Nationwide distribution in the states of AL CA CT FL GA IL IN KS KY LA ME MI MO MS NC ND NE NH NY OH OK SD TN TX VA and WI
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1920-2019, Z-1922-2019, Z-1919-2019, Z-1921-2019

SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by
SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by
SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by c
SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by

Terminated Class II Medical devices

Recall started: 28 May 2019
Terminated: 31 March 2023
Reason: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
Distribution: US Nationwide distributed in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and Puerto Rico.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1915-2019, Z-1917-2019, Z-1918-2019, Z-1916-2019

SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by compute
SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by comp
SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by compu
SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by comp

Terminated Class II Medical devices

Recall started: 9 April 2019
Terminated: 23 April 2020
Reason: In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL,AR, AZ, CA, FL, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, VA , WA WI and WV. and Foreign countries.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1340-2019, Z-1342-2019, Z-1341-2019, Z-1339-2019

Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but
Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures
Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures
Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional proced

Terminated Class II Medical devices

Recall started: 22 March 2019
Terminated: 12 May 2020
Reason: Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists
Distribution: US Nationwide Distribution in the states of NC, MA
Initiated: Voluntary: Firm initiated
Recall number: Z-1295-2019

Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during cl

Terminated Class II Medical devices

Recall started: 21 March 2019
Terminated: 11 January 2022
Reason: There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.
Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1112-2019, Z-1113-2019

syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volu
syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volu

Terminated Class II Medical devices

Recall started: 20 March 2019
Terminated: 18 June 2020
Reason: Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the Auto Field Sequence (AFS) Automatic Motion Protection (AMP) function implemented at the control of the Digital Linear Accelerator.
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-1204-2019

Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS

Terminated Class II Medical devices

Recall started: 18 March 2019
Terminated: 16 April 2020
Reason: Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a result, risk of premature failure of the Monoblock and loss of imaging X-rays.
Distribution: US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
Initiated: Voluntary: Firm initiated
Recall number: Z-1298-2019

Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clin

Terminated Class II Medical devices

Recall started: 14 February 2019
Terminated: 1 May 2020
Reason: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1247-2019, Z-1244-2019, Z-1245-2019, Z-1246-2019

SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and process cross-sectional
SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

Terminated Class II Medical devices

Recall started: 8 February 2019
Terminated: 5 May 2020
Reason: The swivel arm holding the monitors may become dislodged from the carrying arm.
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0985-2019, Z-0984-2019

Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and mini

Ongoing Class II Medical devices

Recall started: 28 January 2019
Reason: The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware
Distribution: Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL,IA, IN, KY, LA, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY; and countries of: Albania, Algeria, Angola, Argentina, Australia,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2351-2019, Z-2352-2019, Z-2353-2019, Z-2350-2019

ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound i
ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004297 The AC
ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303
ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imagin

Terminated Class II Medical devices

Recall started: 30 November 2018
Terminated: 2 September 2020
Reason: Improper design or specifications.
Distribution: Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KY, LA, MD, ME, MN, NJ, NM, NV, NY, OH, OK, PA, TN, TX, and VA and the countries of Argentina, Australia, Bahrain, Belarus, Belgium, Brazil, Chile, China, Colombia, France, Germany, India, Iran, Ireland, Ita
Initiated: Voluntary: Firm initiated
Recall number: Z-0707-2019

Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of

Terminated Class II Medical devices

Recall started: 29 November 2018
Terminated: 7 May 2020
Reason: A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface.
Distribution: The products were distributed to the following US states: NJ.
Initiated: Voluntary: Firm initiated
Recall number: Z-0936-2019

Sensis Vibe System, Model Number 11007642, with software version VD10B.

Terminated Class II Medical devices

Recall started: 26 October 2018
Terminated: 12 May 2020
Reason: This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. The Artis zee system may lose coolant due to a possible leakage in a hose of the cooling unit in the X-ray tube. This will cause the X-ray tube not to be sufficiently cooled down. As a result, the system will display a message Tube hot, have a break . The X-ray will be blocked several minutes later and to prevent any damage to the machine the following message will be displayed NO XRAY, TUBE TOO HOT . This issue is very sporadic and may occur during an ongoing clinical procedure. Use of this product may have a potential impact on planned procedures as they may be delayed as well as in emergent cases, as clinical treatment may need to be terminated and transferred to a functioning system.
Distribution: US Distribution to states of: AR, CA, KS, KY, MD, MN, NM, OK, PA, RI, TX, and UT.
Initiated: Voluntary: Firm initiated
Recall number: Z-0558-2019

Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited t

Terminated Class II Medical devices

Recall started: 19 October 2018
Terminated: 27 April 2020
Reason: Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0458-2019, Z-0459-2019, Z-0457-2019

ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures incl
ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures i
ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedur

Terminated Class II Medical devices

Recall started: 5 October 2018
Terminated: 11 February 2021
Reason: The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,
Distribution: Worldwide
Initiated: Voluntary: Firm initiated
Recall number: Z-0372-2019

EVO Excel, Emission Computed Tomographic System, Material Number 10910501

Terminated Class II Medical devices

Recall started: 28 September 2018
Terminated: 11 February 2021
Reason: The terminals on the plug may become loose and overheat.
Distribution: Worldwide Distribution: US (nationwide) and countries of: Argentina, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Brunnel, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0178-2019, Z-0177-2019

Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 102486
Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PE

Terminated Class II Medical devices

Recall started: 6 August 2018
Terminated: 10 April 2020
Reason: In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope, which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning.
Distribution: The products were distributed to the following US states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NM, NV, NY, OH, OK, PA, PR, SC, SD, TX, UT, VA, WI, and WY.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0300-2019, Z-0299-2019, Z-0298-2019

Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.
Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.
AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body.

Terminated Class II Medical devices

Recall started: 3 August 2018
Terminated: 26 November 2019
Reason: Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning
Distribution: US nationwide distribution
Initiated: Voluntary: Firm initiated
Recall number: Z-0297-2019

Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with T

Terminated Class II Medical devices

Recall started: 29 July 2018
Terminated: 17 May 2019
Reason: Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
Distribution: US nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-3190-2018, Z-3189-2018

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355

Terminated Class II Medical devices

Recall started: 29 June 2018
Terminated: 4 October 2019
Reason: In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break without triggering the safety lock and this could lead to overloading the safety rope which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down during patient positioning. Patients and users may be seriously injured.
Distribution: US Nationwide Distribution to accounts in IL, FL, and NY.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2838-2018, Z-2837-2018

3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector
3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tub

Terminated Class II Medical devices

Recall started: 22 June 2018
Terminated: 15 January 2020
Reason: Potential hardware issue which may cause thermal effects and possible damage to system parts.
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2748-2018, Z-2747-2018

ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnosti

Terminated Class II Medical devices

Recall started: 30 May 2018
Terminated: 14 February 2020
Reason: During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).
Distribution: The devices were distributed to the following US states: AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, ME, NJ, NY, OH, TN, TX, UT, and VA.
Initiated: Voluntary: Firm initiated
Recall number: Z-2524-2018

ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000

Terminated Class II Medical devices

Recall started: 29 May 2018
Terminated: 24 August 2020
Reason: Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biograph mCT and Biograph mCT Flow systems.
Distribution: Worldwide Distribution
Initiated: Voluntary: Firm initiated
Recall number: Z-2248-2018

Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomog

Terminated Class II Medical devices

Recall started: 25 May 2018
Terminated: 16 May 2019
Reason: Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
Distribution: HI , IL, MI, NC, NY, VA, WI
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2525-2018, Z-2526-2018

AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.

Terminated Class II Medical devices

Recall started: 1 May 2018
Terminated: 16 May 2019
Reason: After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Distribution: Worldwide distribution. US nationwide including Puerto Rico, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Myanmar, Netherlands, New
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2307-2018, Z-2306-2018, Z-2303-2018, Z-2304-2018, Z-2309-2018, Z-2314-2018, Z-2313-2018, Z-2308-2018, Z-2310-2018, Z-2311-2018, Z-2305-2018, Z-2312-2018

Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures.
Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures.
Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures.
Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.
Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures.
Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
Artis zee MP, Material no. 10094139, for angiography and whole body radiographic/fluoroscopic procedures.
Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures.
and 4 more product lines

Completed Class II Medical devices

Recall started: 1 May 2018
Terminated: 18 March 2020
Reason: If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.
Distribution: Healthcare facilities in AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, NE, NJ, NY, OH, TN, TX, UT, and VA. Foreign distribution to Australia, Austria, Belgium, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Ar
Initiated: Voluntary: Firm initiated
Recall number: Z-2283-2018

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

Terminated Class II Medical devices

Recall started: 20 April 2018
Terminated: 23 May 2019
Reason: There is a potential for a software issue that may cause the need for necessary patient rescans.
Distribution: Worldwide Distribution: US (nationwide) including states of: AR, CA, CT, FL, GA, IL, IN, KS, KY, MO, ND, NY, OH, OK, SD, TN, TX, and VA; and countries of: Algeria, Australia, Austria, Bangladesh, Bolivia, Bosnia Herzog., Brazil, Cambodia, Chile, China, Columbia, Costa Rica, Germany, Greece, India, I
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1940-2018, Z-1939-2018

SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.

Terminated Class II Medical devices

Recall started: 27 March 2018
Terminated: 15 June 2020
Reason: Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values.
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-1778-2018

Syngo.Via VB20A model 1049610

Terminated Class II Medical devices

Recall started: 5 March 2018
Terminated: 26 February 2021
Reason: The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
Distribution: Distribution was made to medical facilities in AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NJ, NY, NC, OH, PA, TX, VA, and WA. There was no military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Bosnia Herzeg, Colombia, Croatia, Denmark, France
Initiated: Voluntary: Firm initiated
Recall number: Z-1200-2018

ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.

Terminated Class II Medical devices

Recall started: 21 February 2018
Terminated: 12 October 2018
Reason: Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module.
Distribution: Domestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.
Initiated: Voluntary: Firm initiated
Recall number: Z-1930-2018

Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Terminated Class II Medical devices

Recall started: 20 February 2018
Terminated: 16 July 2019
Reason: Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
Distribution: USA (nationwide)
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1699-2018, Z-1700-2018

Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and
Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the

Terminated Class II Medical devices

Recall started: 15 February 2018
Terminated: 8 April 2020
Reason: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
Distribution: USA (nationally) Distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1451-2018, Z-1457-2018, Z-1449-2018, Z-1456-2018, Z-1452-2018, Z-1447-2018, Z-1458-2018, Z-1455-2018, Z-1450-2018, Z-1446-2018, Z-1448-2018, Z-1459-2018 and 3 more

SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
and 7 more product lines

Terminated Class II Medical devices

Recall started: 14 February 2018
Terminated: 16 May 2019
Reason: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
Distribution: Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1402-2018, Z-1397-2018, Z-1400-2018, Z-1401-2018, Z-1398-2018, Z-1399-2018

PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.

Terminated Class II Medical devices

Recall started: 1 February 2018
Terminated: 1 May 2020
Reason: A potential risk of unnecessary radiation exposure due to a software issue
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2472-2018, Z-2475-2018, Z-2474-2018, Z-2477-2018, Z-2478-2018, Z-2473-2018, Z-2476-2018

SOMATOM Emotion 6 (Model 10165888)
SOMATOM Perspective 16 (Model 10891666)
SOMATOM Perspective (Model 10495568)
SOMATOM Scope Power (Model 10967888)
SOMATOM Spirit(Model 10045692 )
SOMATOM Emotion 16 (10165977)
SOMATOM Scope ( Model 10967666)

Terminated Class II Medical devices

Recall started: 26 January 2018
Terminated: 12 October 2018
Reason: Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data reconstruction, incorrect values are being applied. This can lead to a gradient in the image. The severity of the error is directly related to the positioning of the PET QC phantom relative to the center of the field of view.
Distribution: Worldwide distribution. US nationwide, Australia, France, India, Japan, and Netherlands.
Initiated: Voluntary: Firm initiated
Recall number: Z-1597-2018

Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.

Terminated Class II Medical devices

Recall started: 26 January 2018
Terminated: 2 July 2020
Reason: The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.
Distribution: Worldwide Distribution - U.S. nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Brazil, Brunei, Canada, Chile, China, Columbia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Malaysia, Malta,
Initiated: Voluntary: Firm initiated
Recall number: Z-1065-2018

ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Periph

Terminated Class II Medical devices

Recall started: 12 January 2018
Terminated: 28 August 2018
Reason: Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.
Distribution: US Distribution to the states of : AL, AR, CA, FL, IN, LA, MI, MO, NC, NY, PA, TX, and WA.
Initiated: Voluntary: Firm initiated
Recall number: Z-1148-2018

Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Pr

Terminated Class II Medical devices

Recall started: 10 January 2018
Terminated: 2 October 2018
Reason: When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. Due to the disabled cleanup function, disc capacity for free space decreases faster than usual. Unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "Not to be archived" must be manually prevented from being deleted by either clinical administrator or service engineer.
Distribution: Medical device software which needs to be installed.
Initiated: Voluntary: Firm initiated
Recall number: Z-1261-2018

Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based so

Terminated Class II Medical devices

Recall started: 8 January 2018
Terminated: 22 April 2020
Reason: A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
Distribution: Device is software only. No products are distributed to wholesale dealers, distributers or retailers
Initiated: Voluntary: Firm initiated
Recall number: Z-1303-2018

Syngo.via. Medical Device Software. Picture archiving and communications system.

Terminated Class II Medical devices

Recall started: 5 January 2018
Terminated: 23 August 2018
Reason: Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Distribution: US Distribution in the following U.S. states: AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, and TX.
Initiated: Voluntary: Firm initiated
Recall number: Z-1150-2018

AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedur

Terminated Class II Medical devices

Recall started: 8 November 2017
Terminated: 18 May 2023
Reason: There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
Distribution: Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1745-2018, Z-1746-2018, Z-1747-2018, Z-1748-2018

SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system

Terminated Class II Medical devices

Recall started: 2 October 2017
Terminated: 27 September 2018
Reason: The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.
Distribution: US Nationwide Distribution in the states of FL, MO, NY, TN
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0713-2018, Z-0714-2018

SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission da
SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission d

Terminated Class II Medical devices

Recall started: 28 September 2017
Terminated: 9 March 2020
Reason: The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.
Distribution: Distributed in XX states: Ak, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, the District of Columbia, Guam, and Puerto Rico.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0709-2018, Z-0710-2018, Z-0711-2018

Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.

Terminated Class II Medical devices

Recall started: 31 August 2017
Terminated: 1 October 2018
Reason: A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system.
Distribution: Nationwide Distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-0808-2018

Syngo.via systems with SW VB20A

Terminated Class II Medical devices

Recall started: 24 August 2017
Terminated: 29 August 2018
Reason: Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality inspection will be initiated to ensure all screws in the rotation unit meet quality standards.
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall number: Z-0508-2018

AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited t

Terminated Class II Medical devices

Recall started: 23 August 2017
Terminated: 1 October 2018
Reason: When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be replaced in the active Workflow Step and not show in all other workflow steps. The other workflow steps will continue to show the initially loaded study.
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall number: Z-0524-2018

Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate

Terminated Class II Medical devices

Recall started: 22 August 2017
Terminated: 21 August 2018
Reason: The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen
Distribution: US Distribution to the states of : AR, MO, NY, IN, AR, TX , NC, PA, MI, LA, WA, CA and AL.
Initiated: Voluntary: Firm initiated
Recall number: Z-0614-2018

Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, b

Terminated Class II Medical devices

Recall started: 18 August 2017
Terminated: 30 August 2018
Reason: Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to inadequate permissions for shared folders.
Distribution: USA (nationwide) Distribution to the states of : AL, CT, FL, KS, LA, MA, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX and WI. Foreign consignees were not reported as device is manufactured outside the U.S.
Initiated: Voluntary: Firm initiated
Recall number: Z-0495-2018

Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device

Terminated Class II Medical devices

Recall started: 25 July 2017
Terminated: 23 July 2018
Reason: Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
Distribution: USA (nationwide) Distribution to the states of: MA, CA, NC, WI, NY, NE, PA, AL, NJ, MO, MI, TX, MS, KS, LA, CT, MD, LA, CO, OK, MN and TN.
Initiated: Voluntary: Firm initiated
Recall number: Z-0405-2018

Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including

Terminated Class II Medical devices

Recall started: 6 June 2017
Terminated: 16 May 2019
Reason: Potential for liquid entry
Distribution: U.S. Nationwide
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0708-2018, Z-0706-2018, Z-0707-2018

Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355
Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354

Terminated Class II Medical devices

Recall started: 31 March 2016
Terminated: 29 October 2020
Reason: E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may lose some detector time information. Our risk analysis indicates that the probability of occurrence is remote. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Initiated: Voluntary: Firm initiated
Recall number: Z-2898-2020

E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomogra

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.