Waukesha, WI, United States
GE Healthcare, LLC recalls
114 recalls recorded since 2018, most recently on 31 July 2026. 50 are listed as ongoing. Status and classification are as published by the FDA.
Recalls114
Ongoing (FDA)50
Terminated or completed64
Class I (FDA)8
Ongoing Class II Medical devices
- Recall started
- 31 July 2026
- Reason
- Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3169-2026, Z-3168-2026, Z-3166-2026, Z-3171-2026, Z-3170-2026, Z-3167-2026
- Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
- Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from
- Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
- Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
- Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions
- Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
Ongoing Class II Medical devices
- Recall started
- 27 February 2026
- Reason
- Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, MA, NJ, NY, OH, SD, TX, VA, PR and the countries of Sweden, Switzerland, United Kingdom, Vietnam, China, Norway, Portugal, Spain, France, Germany, Greece, Korea, Republic of
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1767-2026
Ongoing Class II Medical devices
- Recall started
- 16 January 2026
- Reason
- Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belarus, Brazil, Canada, China, France, Georgia, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Lebanon, Malaysia, Netherlands, Philippines, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spai
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1475-2026
- GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
Ongoing Class II Medical devices
- Recall started
- 3 November 2025
- Reason
- GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0935-2026
- GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Ongoing Class II Medical devices
- Recall started
- 19 February 2025
- Reason
- There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1487-2025, Z-1485-2025, Z-1484-2025, Z-1486-2025, Z-1483-2025
- GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.
- GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 20980
- GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.
- GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2
- GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-110; 9) 2088026-11
Ongoing Class II Medical devices
- Recall started
- 3 October 2024
- Reason
- GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which could allow a malicious actor to access the system and potentially manipulate patient data.
- Distribution
- Worldwide distribution - United States Nationwide and the countries of Algeria, Argentina, Brazil, China, Dominican Republic, France, Germany, India, Indonesia, Ireland, Israel, Japan, Kuwait, Malaysia, Mexico, Panama, Qatar, Russia, Saudi Arabia, Singapore, Spain, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0318-2025
- GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Un
Ongoing Class II Medical devices
- Recall started
- 29 August 2024
- Reason
- GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0039-2025
- GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 208
Ongoing Class II Medical devices
- Recall started
- 8 August 2024
- Reason
- The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.
- Distribution
- US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3146-2024, Z-3145-2024
- ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
- ViewPoint; system, imaging processing, radiological
Ongoing Class II Medical devices
- Recall started
- 5 August 2024
- Reason
- GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3214-2024
- GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Ongoing Class II Medical devices
- Recall started
- 23 July 2024
- Reason
- Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers. " Internet Explorer 10 (IE10) " Internet Explorer 11 (IE11) " Firefox.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3160-2024
- GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344
Ongoing Class II Medical devices
- Recall started
- 14 September 2023
- Reason
- GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
- Distribution
- US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Netherlands Antilles, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, Viet
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0139-2024, Z-0140-2024, Z-0138-2024
- Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
- Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System
- Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
Ongoing Class II Medical devices
- Recall started
- 8 September 2023
- Reason
- When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.
- Distribution
- Nationwide distribution to AR, AZ, CA, CO, DE, FL, GA, IL, IN, ME, MI, MN, MO, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX. International distribution to Austria, Canada, France, Germany, Hong Kong, Israel, Italy, Philippines, Singapore, Thailand, Turkey, Vietnam.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0143-2024, Z-0142-2024
- Universal Viewer Workflow Manager, Image processing radiological system
- Centricity Universal Viewer Workflow Manager, Image processing radiological system
Ongoing Class II Medical devices
- Recall started
- 28 March 2023
- Reason
- GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1500-2023, Z-1501-2023, Z-1502-2023
- Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Processing System
- Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-30
- Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System
Ongoing Class II Medical devices
- Recall started
- 15 July 2022
- Reason
- Inaccurate Distance and Area measurements with use of Global Stack viewport.
- Distribution
- Distribution was made to AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, WA, WI, and WV. There was government distribution and no military distribution. Foreign distribution was made to Argentina, A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1566-2022
- (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
Ongoing Class II Medical devices
- Recall started
- 24 June 2022
- Reason
- Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, MI, MN, NY, and WI. There was government distribution but no military distribution. The countries of China, France, Hong Kong, India, Italy, Japan, Korea, Kuwait, Norway, Oman, Saudi Arabia, Slovakia, Spain, Sweden, Sw
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1430-2022
- SIGNA Premier magnetic resonance scanner, model 5748519.
Terminated Class II Medical devices
- Recall started
- 14 June 2022
- Terminated
- 16 January 2024
- Reason
- The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1466-2022
- Centricity PACS Software Version 7.0 SP0.0.4.7
Ongoing Class II Medical devices
- Recall started
- 8 June 2022
- Reason
- Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1333-2022
- GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.
Ongoing Class II Medical devices
- Recall started
- 2 June 2022
- Reason
- As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.
- Distribution
- US Nationwide distribution including PR. There was also government/military distribution. The countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State of Bolivia, Bosnia and Herzegovina
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1511-2022
- Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE
Terminated Class I Medical devices
- Recall started
- 1 June 2022
- Terminated
- 21 October 2024
- Reason
- There is a potential reversal of the O2 and air cylinder pressure transducer connections.
- Distribution
- Worldwide Distribution. US nationwide, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kenya, Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1389-2022
- GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
Ongoing Class II Medical devices
- Recall started
- 27 May 2022
- Reason
- The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.
- Distribution
- Distribution was made to AZ, CA, CO, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MT, NC, NE, NV, NY, OH, PA, SC, TN, TX, VA, and WV. There was also military distribution but no government distribution. Foreign distribution was made to Australia, Canada, China, Estonia, Finland, France, G
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1427-2022
- GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
Ongoing Class II Medical devices
- Recall started
- 10 May 2022
- Reason
- The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station.
- Distribution
- Worldwide distribution - US Nationwide. There was also military/government distribution and the countries of Algeria, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Costa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1265-2022
- CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER
Ongoing Class II Medical devices
- Recall started
- 28 April 2022
- Reason
- Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
- Distribution
- Worldwide distribution. Nationwide distribution to AL, AR, AZ, CA, CO, CT, DC, 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, VT, WA, WI, WV, WY. International distribution to Argentina, Aust
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1231-2022, Z-1229-2022, Z-1230-2022, Z-1232-2022, Z-1233-2022
- Centricity Radiology RA600
- Centricity Universal Viewer Zero Footprint Client
- Centricity Enterprise Web
- Centricity Cardiology CA1000
- Centricity PACS RA1000
Ongoing Class II Medical devices
- Recall started
- 25 April 2022
- Reason
- Backup batteries can fail earlier than their estimated life.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Italy, Japan, Kazakhstan, Kenya, Korea, Kuwait, Lao P
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1285-2022, Z-1286-2022
- Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
- Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices
Ongoing Class I Medical devices
- Recall started
- 18 April 2022
- Reason
- Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
- Distribution
- Worldwide Distribution: US (nationwide) to AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and OUS (internationally) to Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Chi
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1227-2022, Z-1226-2022
- Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
- Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
Terminated Class II Medical devices
- Recall started
- 16 March 2022
- Terminated
- 4 May 2026
- Reason
- Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
- Distribution
- US and Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, England, France, Germany, Ireland, Italy, Korea, Malaysia, Netherlands, Norway, Poland, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Taiwan, Turkey
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0919-2022
- MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Ongoing Class II Medical devices
- Recall started
- 4 March 2022
- Reason
- During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
- Distribution
- Worldwide Distribution: US (nationwide), including Puerto Rico and the U.S. Virgin Islands; and OUS (Foreign) was made to Albania, Algeria, Argentina, Armenia, ASEAN HQ, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0983-2022
- GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA
Ongoing Class II Medical devices
- Recall started
- 18 February 2022
- Reason
- There is potential for the images to be flipped left to right.
- Distribution
- Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Po
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0857-2022, Z-0859-2022, Z-0858-2022, Z-0860-2022
- Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
- SIGNA Excite 3T. Magnetic Resonance Imaging System
- 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
- 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
Ongoing Class II Medical devices
- Recall started
- 28 January 2022
- Reason
- If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
- Distribution
- Worldwide distribution - US nationwide, including Puerto Rico. There was also government/military distribution. The countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cote d'lvoire,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0808-2022
- GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
Ongoing Class II Medical devices
- Recall started
- 23 December 2021
- Reason
- The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Distribution
- Distribution was nationwide, including Puerto Rico and the Virgin Islands. There was also government and military distribution. Foreign distribution was made to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaidjan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia and
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0600-2022, Z-0604-2022, Z-0612-2022, Z-0599-2022, Z-0591-2022, Z-0608-2022, Z-0592-2022, Z-0609-2022, Z-0615-2022, Z-0613-2022, Z-0619-2022, Z-0605-2022 and 20 more
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.
- GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic resonance imaging system.
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.
- GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.
- and 24 more product lines
Terminated Class II Medical devices
- Recall started
- 4 November 2021
- Terminated
- 24 July 2026
- Reason
- The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
- Distribution
- Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, 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, PR, and DC. International: Albania, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia, Braz
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0522-2022, Z-0520-2022, Z-0521-2022, Z-0523-2022, Z-0524-2022, Z-0518-2022, Z-0519-2022
- GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
- GE Vscan Extend, being sold as "Vscan Extend Dual USB"
- GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
- GE Vscan Extend, being sold as "Vscan Extend Sector USB"
- GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
- GE Vscan Extend, being sold as "Vscan Extend Console"
- GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
Terminated Class II Medical devices
- Recall started
- 15 October 2021
- Terminated
- 17 August 2026
- Reason
- There is a potential to display incomplete patient imaging study.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WA, and WV. The countries of Argentina, Aruba, Australia, Belgium, Bolivia, Brazil, Canada, Chile,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0329-2022
- GE Centricity Universal Viewer Zero Footprint Client
Terminated Class II Medical devices
- Recall started
- 26 August 2021
- Terminated
- 4 May 2026
- Reason
- Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- Distribution
- Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0134-2022, Z-0140-2022, Z-0141-2022, Z-0133-2022, Z-0137-2022, Z-0135-2022, Z-0138-2022, Z-0139-2022, Z-0136-2022, Z-0132-2022
- SIGNA Pioneer nuclear magnetic resonance imaging system
- Optima MR450w 1.5T nuclear magnetic resonance imaging system
- 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
- SIGNA Architect nuclear magnetic resonance imaging system
- SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
- Discovery MR750w 3.0T nuclear magnetic resonance imaging system
- SIGNA Voyager nuclear magnetic resonance imaging system
- SIGNA Artist nuclear magnetic resonance imaging system
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 12 August 2021
- Terminated
- 22 August 2024
- Reason
- A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).
- Distribution
- AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0012-2022
- Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Ongoing Class II Medical devices
- Recall started
- 6 August 2021
- Reason
- Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
- Distribution
- AK, AZ, CA, CO, DE, FL, GA, IA, IN, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, WA, WI, WV and WY. Austria, Brazil, Canada, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Netherlands, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Afric
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2503-2021, Z-2502-2021
- Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number:
- Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
Ongoing Class II Medical devices
- Recall started
- 2 August 2021
- Reason
- The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
- Distribution
- Distribution was nationwide, including PR. Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote D'lvo
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2596-2021, Z-2595-2021
- Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 10
- Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blu
Ongoing Class II Medical devices
- Recall started
- 30 June 2021
- Reason
- When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.
- Distribution
- US
- Initiated
- FDA Mandated
- Recall numbers
- Z-2023-2021, Z-2022-2021, Z-2021-2021
- The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and G
- The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to
- The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to
Ongoing Class II Medical devices
- Recall started
- 30 June 2021
- Reason
- The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.
- Distribution
- Worldwide and US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall number
- Z-0242-2022
- Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Ongoing Class II Medical devices
- Recall started
- 30 June 2021
- Reason
- The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- FDA Mandated
- Recall numbers
- Z-0815-2022, Z-0816-2022
- Revolution Apex, Revolution CT with Apex Edition
- Revolution CT, Revolution CT ES
Terminated Class II Medical devices
- Recall started
- 24 June 2021
- Terminated
- 14 June 2023
- Reason
- An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
- Distribution
- Domestic Distribution Only
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2590-2021
- AMX Navigate Mobile X-Ray System
Ongoing Class II Medical devices
- Recall started
- 14 June 2021
- Reason
- Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
- Distribution
- 3,665 (US = 956; OUS = 2,709)
- Initiated
- FDA Mandated
- Recall number
- Z-1900-2021
- Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Ongoing Class II Medical devices
- Recall started
- 4 June 2021
- Reason
- GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
- Distribution
- Worldwide distributions.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2052-2021, Z-2061-2021, Z-2057-2021, Z-2055-2021, Z-2065-2021, Z-2064-2021, Z-2060-2021, Z-2059-2021, Z-2063-2021, Z-2056-2021, Z-2058-2021, Z-2053-2021 and 2 more
- SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- SIGNA Artist, Nuclear Magnetic Resonance Imaging System
- SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
- Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
- Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
- SIGNA MR380, Nuclear Magnetic Resonance Imaging System
- SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
- and 6 more product lines
Ongoing Class II Medical devices
- Recall started
- 21 May 2021
- Reason
- Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
- Distribution
- worldwide distribution US nationwide, Albania, Algeria, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Fij
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2139-2021
- CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Terminated Class II Medical devices
- Recall started
- 19 April 2021
- Terminated
- 31 August 2023
- Reason
- The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, GA, KY, LA, MA, MO, MS, NC, NJ, NV, NY, PA, SC, TN, TX, VA, WA, and WI. Government distribution was made and potentially military distribution was made. The countries of Algeria, Argentina, Canada, China, Dominican
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1864-2021
- GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional
Terminated Class II Medical devices
- Recall started
- 19 April 2021
- Terminated
- 14 January 2026
- Reason
- If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an Electronic Medical Record (EMR) or a similar system.
- Distribution
- Worldwide distribution - US Nationwide. Government/military distribution was also made, and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belgium, Bermuda, Brazil, Brunei Darussalam, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1927-2021
- Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
Terminated Class II Medical devices
- Recall started
- 19 March 2021
- Terminated
- 11 August 2023
- Reason
- When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially include a different patient s comparison exam(s).
- Distribution
- Distributed nationwide to AR, CA, CO, DE, FL, IL, IN, LA, ME, NE, NJ, NV, NY, PA, SC, TX and internationally to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1533-2021
- Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Completed Class II Medical devices
- Recall started
- 19 March 2021
- Reason
- GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
- Distribution
- Worldwide distribution - US Nationwide
- Initiated
- FDA Mandated
- Recall number
- Z-2004-2021
Ongoing Class II Medical devices
- Recall started
- 7 February 2021
- Reason
- GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.
- Distribution
- Worldwide distribution - US Nationwide
- Initiated
- FDA Mandated
- Recall numbers
- Z-1546-2021, Z-1547-2021, Z-1545-2021
- NM/CT 860 Nuclear Medicine / CT Scanners
- NM/CT 870 DR Nuclear Medicine / CT Scanners
- NM/CT 850 Nuclear Medicine / CT Scanners
Terminated Class II Medical devices
- Recall started
- 17 December 2020
- Terminated
- 9 January 2023
- Reason
- GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
- Distribution
- Worldwide - US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NV, NY, NH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV; In the countries of Algeria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Braz
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1130-2021, Z-1129-2021
- System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
- System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
Terminated Class II Medical devices
- Recall started
- 10 December 2020
- Terminated
- 21 August 2026
- Reason
- GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0855-2021, Z-0856-2021, Z-0857-2021, Z-0853-2021, Z-0854-2021, Z-0858-2021
- GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
- Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope
- Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare profess
- GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
- GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
- Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Terminated Class II Medical devices
- Recall started
- 10 December 2020
- Terminated
- 18 November 2022
- Reason
- GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A partial detachment of the monitor suspension could result in potential injury to a patient or operator.
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1101-2021
- GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic
Terminated Class II Medical devices
- Recall started
- 23 November 2020
- Terminated
- 29 August 2023
- Reason
- A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0694-2021, Z-0695-2021
- Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Terminated Class II Medical devices
- Recall started
- 27 October 2020
- Terminated
- 3 May 2024
- Reason
- Incorrect patient identification and/or patient demographic errors.
- Distribution
- Domestic Distribution: AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International Distribution: AUSTRALIA, AUSTRIA, BELGIUM, Canada, CZECH REP
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0543-2021
- MAC VU360, Electrocardiograph
Terminated Class II Medical devices
- Recall started
- 21 September 2020
- Terminated
- 28 December 2022
- Reason
- There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, NC, NE, NJ, PA, TX, VA, WA, and WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Estonia, Finland, France, Japan, Kuwait, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Thailand
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0306-2021
- Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Ongoing Class II Medical devices
- Recall started
- 17 September 2020
- Reason
- Flow sensors could have damaged tubes in the form of small punctures or cuts.
- Distribution
- U.S. states where product was distributed - AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI Foreign countries impacted - Australia, Canada, Czech Republic, Estonia, France, Germany, India, Indonesia, Is
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0315-2021, Z-0311-2021, Z-0314-2021, Z-0312-2021, Z-0317-2021, Z-0316-2021, Z-0313-2021
- Flow Sensor Service Part, Catalog 2089610-001-S
- Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR
- 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
- GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for
- Flow Sensor Service Part, Catalog 2096513-001-S
- Flow Sensor Service Part, Catalog 2087640-001-S
- GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended fo
Terminated Class II Medical devices
- Recall started
- 8 September 2020
- Terminated
- 28 April 2021
- Reason
- Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0130-2021, Z-0127-2021, Z-0129-2021, Z-0128-2021, Z-0131-2021
- System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality M
Terminated Class II Medical devices
- Recall started
- 14 August 2020
- Terminated
- 6 May 2021
- Reason
- Rotor bearing screws were found loose on detector.
- Distribution
- USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2991-2020, Z-2994-2020, Z-2997-2020, Z-2998-2020, Z-2993-2020, Z-2995-2020, Z-2996-2020, Z-2992-2020
- NM/CT 850 Model Number: H3907AD
- Discovery NM 630 Model # H3101RH
- Discovery NM670 Pro Model # H3100XB
- NM/CT 870 DR Model # H3100AS
- NM/CT 870 CZT Model # H3906CW
- NM 830 Model # H3910AC
- Discovery 670 DR Model # H3100BT
- NM/CT 860, SPECT/CT
Terminated Class II Medical devices
- Recall started
- 14 July 2020
- Terminated
- 23 September 2024
- Reason
- The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
- Distribution
- Domestic Distribution: USA International Distribution: Australia, Bahrain, Bermuda, Canada, Egypt, France, Germany, Honduras, India, Iraq, Italy, Lebanon, Mexico, Panama, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Taiwan and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2883-2020
- CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Vol
Terminated Class II Medical devices
- Recall started
- 22 June 2020
- Terminated
- 19 August 2024
- Reason
- CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of MT, NC, TX and WI. The countries of Australia, Austria, Bahrain,Belgium, Bolivia, Brazil ,Canada, Chile, Check Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungar
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2750-2020
- CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hos
Ongoing Class II Medical devices
- Recall started
- 18 May 2020
- Reason
- The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and if an Automated External Defibrillator (AED) is used to perform defibrillation, the low frequency signals deployed by the AED, cause the PDM to issue a false flat line ECG waveform and alarm Asystole to be displayed on the monitor.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2424-2020
- CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-0
Ongoing Class II Medical devices
- Recall started
- 8 May 2020
- Reason
- GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE) change the dose value on the live update screen from AKR / CAK to DAP. All systems sold to customers in the US that leave GEHC Surgery (the place of manufacture) are configured to display AKR / CAK when they leave the factory. An FSE changing the dose display, per the customer request, to display DAP instead does not comply to 21CFR 1020.32(k), which requires fluoroscopic equipment manufactured on or after June 10, 2006 to display continuous updates of AKR and CAK values.
- Distribution
- Nationwide
- Initiated
- FDA Mandated
- Recall number
- Z-2872-2020
- The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscop
Terminated Class II Medical devices
- Recall started
- 28 April 2020
- Terminated
- 23 September 2024
- Reason
- Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.
- Distribution
- Worldwide Distribution. US nationwide including US Virgin Islands, Australia, Austria, Bahrain, Belgium, Bermuda, Bulgaria, Burundi, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, Fra
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2236-2020, Z-2235-2020
- Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
- Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Terminated Class II Medical devices
- Recall started
- 2 April 2020
- Terminated
- 6 May 2024
- Reason
- During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, LA, MD, MI, MS, NC, ND, NM, NV, NY, OH, Ok, OR, PA, SC, TN, TX, VA, WA, WI and WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2111-2020
- Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Terminated Class II Medical devices
- Recall started
- 23 December 2019
- Terminated
- 11 December 2020
- Reason
- It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
- Distribution
- Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0875-2020, Z-0876-2020, Z-0874-2020, Z-0877-2020
- SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ra
Terminated Class II Medical devices
- Recall started
- 16 December 2019
- Terminated
- 5 October 2023
- Reason
- Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.
- Distribution
- Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0819-2020
- Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Ongoing Class II Medical devices
- Recall started
- 3 December 2019
- Reason
- An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
- Distribution
- US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall numbers
- Z-1709-2020, Z-1710-2020, Z-1712-2020, Z-1711-2020
- Lunar iDXA bone densitometer
- Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
- Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
- Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
Terminated Class I Medical devices
- Recall started
- 25 November 2019
- Terminated
- 30 November 2023
- Reason
- GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Albania, Algeria, Argentina, Australia, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Croatia and Hrvatska, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatem
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0814-2020, Z-0813-2020
- Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
- Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
Terminated Class II Medical devices
- Recall started
- 12 November 2019
- Terminated
- 2 March 2026
- Reason
- When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information Center (CIC) systems were identified to have vulnerabilities to a cyber-attack.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0725-2020, Z-0726-2020, Z-0727-2020
- ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological d
- CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical envir
- CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to
Terminated Class I Medical devices
- Recall started
- 11 October 2019
- Terminated
- 15 August 2024
- Reason
- Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0540-2020, Z-0538-2020, Z-0541-2020, Z-0539-2020
- Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
- Giraffe OmniBed infant warmer
- Giraffe Incubator infant warmer
- Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer
Terminated Class I Medical devices
- Recall started
- 27 September 2019
- Terminated
- 26 September 2023
- Reason
- Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
- Distribution
- US OUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0757-2020, Z-0760-2020, Z-0756-2020, Z-0759-2020, Z-0758-2020, Z-0754-2020, Z-0755-2020
- CARESCAPE Respiratory Module E-sCAiOV
- Airway Gas Option N-CAiO
- CARESCAPE Respiratory Module E-sCAiO
- CARESCAPE Respiratory Module E-sCAiOVE
- CARESCAPE Respiratory Module E-sCAiOE
- CARESCAPE Respiratory Module E-sCO
- CARESCAPE Respiratory Module E-sCOVX
Terminated Class II Medical devices
- Recall started
- 16 September 2019
- Terminated
- 16 December 2020
- Reason
- Potential for failure of the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab II Plus Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient.
- Distribution
- Nationwide distribution to CA, CT, FL, IN, MD, MI , MN, MO, NC, NE, NJ, OH, PA, TX, WI. International distribution to Canada, France, India, Japan, Korea (Republic Of), Mexico, Spain, Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0257-2020
- CardioLab/ComboLab Recording Systems
Terminated Class II Medical devices
- Recall started
- 3 September 2019
- Terminated
- 16 February 2021
- Reason
- Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.
- Distribution
- Nationwide distribution to AZ, GA, MT, NC, NJ, NY, OH, WI. International distribution to Australia, Bahrain, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Cyprus, Hong Kong, India, Iraq, Ireland, Italy, Kuwait, Lebanon, Malaysia, Mauritius, Mexico, MEXICO, Myanmar, Nepal, Oman, Panama, Pe
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0113-2020, Z-0112-2020
- Achilles Express Bone Sonometer
- Achilles Insight Bone Sonometer
Ongoing Class II Medical devices
- Recall started
- 30 August 2019
- Reason
- May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.
- Distribution
- Worldwide distribution - US Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. The countries of ALGERIA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0175-2020
- ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or
Ongoing Class II Medical devices
- Recall started
- 9 August 2019
- Reason
- Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
- Distribution
- Worldwide - US Nationwide
- Initiated
- FDA Mandated
- Recall number
- Z-2449-2019
- Proteus XR/a (SlOK : K993090)
Ongoing Class II Medical devices
- Recall started
- 26 July 2019
- Reason
- Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
- Distribution
- Worldwide distributions - US Nationwide in the states of CA, CT, FL, ID, IL, KS, MI, NC, NC, NJ, NM, PA, TX, VA. Countries of China, France, Germany, Korea, Republic of China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0281-2020
- Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same t
Terminated Class II Medical devices
- Recall started
- 19 July 2019
- Terminated
- 13 April 2026
- Reason
- Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0115-2020, Z-0116-2020, Z-0117-2020, Z-0114-2020
- Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 1006-9033-000 h) 1006-9117-000 i) 1006-9119-000 j) 1006-9030-000 k
- Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 6. 1009-9003-000 7. 1009-9000-000-008120 8. 1009-9000-000-009600 9.
- Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7. 1006-9321-000-007639 8. 1006-9321-000-000023 9. 1006-9321-000-01518
- Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-02
Terminated Class II Medical devices
- Recall started
- 2 July 2019
- Terminated
- 5 October 2020
- Reason
- Potential for a transducer mis-alignment in certain transvaginal probes.
- Distribution
- Distribution in the US to Texas. International distribution to France, Greece and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1964-2019, Z-1965-2019
- Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
- Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Terminated Class II Medical devices
- Recall started
- 28 June 2019
- Terminated
- 13 April 2021
- Reason
- Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being assigned to the incorrect patient.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2060-2019
- MAC VU360, Model Number 2030360-001, Electrocardiograph
Terminated Class II Medical devices
- Recall started
- 22 May 2019
- Terminated
- 20 September 2024
- Reason
- There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1781-2019
- GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x
Ongoing Class II Medical devices
- Recall started
- 21 May 2019
- Reason
- Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
- Distribution
- Worldwide distribution - US nationwide distributed in the states of CA, FL, IL, MA , MD, MI, MN, NY, SC, TX, UT. Countries of Australia, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Korea (Republic Of), Netherlands, Romania, Sweden, Switzerland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1839-2019
- LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi
Terminated Class II Medical devices
- Recall started
- 17 May 2019
- Terminated
- 20 November 2023
- Reason
- There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
- Distribution
- Worldwide Distribution - US Nationwide Austria, Belgium, Brazil Canada Colombia France Germany Ghana India Ireland Israel Italy Kuwait Mexico Netherlands Panama Poland Qatar Russia Saudi Arabia Slovenia South Africa Spain Switzerland Turkey United Arab Emirates United Kingdo
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1885-2019, Z-1886-2019
- Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other
- Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from
Terminated Class II Medical devices
- Recall started
- 16 May 2019
- Terminated
- 14 April 2023
- Reason
- There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: FL, GA, IL, IN, LA, MA, MO, NJ, NY, OR, PA, SC, SD, TX, and WA; and countries of : Brazil, Canada, Chile, France, French Polynesia, Germany, India, Italy, Japan, Kuwait, Lebanon, Singapore, Spain and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1910-2019, Z-1911-2019
- Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
- Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acq
Terminated Class II Medical devices
- Recall started
- 16 May 2019
- Terminated
- 16 December 2020
- Reason
- Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
- Distribution
- Worldwide distribution - US nationwide distribution in the states of AZ, CA, FL, GA, IL, MI, MN, NC, NJ, NY, PA, TX, and VT, and countries of Algeria, Australia, Belgium, Canada, Chile, Columbia, Czech Republic, Finland, France, Germany, Hungary, Iceland, Japan, Korea (Republic of), Kuwait, Lebanon,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2131-2019, Z-2132-2019
- GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the sa
- GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.
Terminated Class III Medical devices
- Recall started
- 10 May 2019
- Terminated
- 24 May 2024
- Reason
- ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
- Distribution
- Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvado
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1878-2019, Z-1877-2019, Z-1875-2019, Z-1879-2019, Z-1876-2019
- Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set,
- Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2
- ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12
- Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requ
- ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106389-003 ECG
Terminated Class II Medical devices
- Recall started
- 29 March 2019
- Terminated
- 15 April 2021
- Reason
- There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Egypt , France, F
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1753-2019, Z-1751-2019, Z-1755-2019, Z-1752-2019, Z-1754-2019
- Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedur
- Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.
- Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
- Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation
- Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
Terminated Class II Medical devices
- Recall started
- 20 March 2019
- Terminated
- 5 October 2020
- Reason
- During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
- Distribution
- US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1264-2019, Z-1265-2019, Z-1259-2019, Z-1266-2019, Z-1261-2019, Z-1263-2019, Z-1262-2019, Z-1258-2019, Z-1260-2019, Z-1257-2019
- NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patien
- NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ functio
- Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and org
- Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpo
- NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient bo
- NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear
- NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medi
- Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in th
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 19 March 2019
- Terminated
- 30 March 2020
- Reason
- The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. This could result in user and/or patient contact with infectious agents since the internal porous material cannot be disinfected.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AZ, CA, MS, NY, WI, DE, and countries of France, Germany, Japan, Netherlands, Spain, Sweden,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0062-2020
- AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems.
Ongoing Class II Medical devices
- Recall started
- 15 March 2019
- Reason
- There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.
- Distribution
- Nationwide distribution to AR, CA, CA, FL, MI, NM, NV, SC, TN, TX, VA, WA, WI. International distribution to Algeria, Belgium, China, Colombia, France, Hungary, Italy, Japan, Korea (Republic Of), Kuwait, Libya, Pakistan, Poland, Russia, Saudi Arabia, South Africa, Sudan, Turkey, Vietnam.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1201-2019, Z-1199-2019, Z-1200-2019
- Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
- Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
- Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Terminated Class I Medical devices
- Recall started
- 15 March 2019
- Terminated
- 21 May 2024
- Reason
- The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.
- Distribution
- Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, 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, VT, WA, WI, WV, WY, Guam, Northern Mariana Island
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1847-2019, Z-1846-2019
- Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facili
- Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to faci
Terminated Class III Medical devices
- Recall started
- 22 February 2019
- Terminated
- 19 August 2020
- Reason
- The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient.
- Distribution
- Worldwide Distribution - US Nationwide to AK, KS, MA, MA, ME, NJ, NJ, NM, NY, TX. Distributed worldwide to Chile, Finland, France, Germany, Italy, Korea (Republic Of), Russia, Spain, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1060-2019
- Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT; 2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC,
Ongoing Class II Medical devices
- Recall started
- 12 February 2019
- Reason
- GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
- Distribution
- Nationwide Distribution
- Initiated
- FDA Mandated
- Recall numbers
- Z-1750-2019, Z-1749-2019, Z-1745-2019, Z-1747-2019, Z-1746-2019, Z-1748-2019
- Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of
- Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of inte
- Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means
- Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by m
- Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means
- Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of int
Ongoing Class II Medical devices
- Recall started
- 19 January 2019
- Reason
- Additional low dose radiation exposure.
- Distribution
- Worldwide - US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall number
- Z-1951-2019
- Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Terminated Class II Medical devices
- Recall started
- 28 December 2018
- Terminated
- 5 October 2020
- Reason
- Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific probes.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0788-2019
- GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pedi
Terminated Class II Medical devices
- Recall started
- 20 December 2018
- Terminated
- 9 April 2021
- Reason
- When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagnosis.
- Distribution
- Worldwide Distribution: US (nationwide) in states of: AZ, CA, CO, DE, FL, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, MT, NE, NJ, NV, NY, OH, PA, PR, SC, SD, TN, TX, VA, VT, and WI; and countries of: Antigua, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Cote d'I
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0793-2019
- GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Me
Ongoing Class II Medical devices
- Recall started
- 30 November 2018
- Reason
- GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.
- Distribution
- Domestic Distribution: AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, IA, IL, IN, KY, LA,MA, MD, ME, MI, MN, MO, MS, NC, NE, NM, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT,VA, WI and WV. Foreign Distribution: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, France, Germany, Ghana, In
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2258-2020, Z-2259-2020
- System, Tomography Computed Emmission
- System, Tomography Computed Emmission
Terminated Class II Medical devices
- Recall started
- 15 November 2018
- Terminated
- 17 January 2021
- Reason
- Possible incorrect software version loaded.
- Distribution
- Worldwide Distribution - US Nationwide AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, VT, WA, WI, WV, and WY Albania, Algeria, Argentina, Armenia, Australia, Austri
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0693-2019
- Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
Terminated Class II Medical devices
- Recall started
- 9 November 2018
- Terminated
- 18 May 2026
- Reason
- Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and vertically, the orientation markers appear correctly on the image to which they were applied. However, once new image rendering happens on this image or series (with scrolling; playing cin¿; maximizing or changing viewports/layouts; or synchronizing viewports and resizing the browser), the new image orientation is correctly maintained but the display of orientation markers can become incorrect. Issue #2 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a, SP8.0.2, SP9 and SP9.0.1. When an image in a series is flipped and then rotated in Zero Footprint Viewer (ZFP), the orientation markers appear correctly on the image to which they were applied. However, once you navigate to another image in the series and the image you navigated to has a different orientation than the prior image from which you navigated, the new image orientation is correctly maintained but the display of orientation markers can become incorrect.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0641-2019
- Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can beco
Terminated Class II Medical devices
- Recall started
- 11 October 2018
- Terminated
- 20 March 2023
- Reason
- Synchronization failure
- Distribution
- CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0374-2019, Z-0375-2019
- Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
- Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
Terminated Class I Medical devices
- Recall started
- 5 October 2018
- Terminated
- 29 April 2024
- Reason
- The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.
- Distribution
- Worldwide Distribution: US (Nationwide) including Puerto Rico, and to countries of: Albania, Argentina, Australia, Austria, Bangladesh, Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greec
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0463-2019
- GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or s
Terminated Class II Medical devices
- Recall started
- 27 September 2018
- Terminated
- 12 April 2021
- Reason
- Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.
- Distribution
- Worldwide distribution - US nationwide in the states of CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, ,MA, MD, MI, MN, MO, MT, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Countries of Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Croatia, Cze
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0411-2019, Z-0412-2019, Z-0413-2019
- Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X U
- Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11
- Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X D
Terminated Class II Medical devices
- Recall started
- 25 September 2018
- Terminated
- 13 July 2020
- Reason
- Potential electric leakage affecting the user.
- Distribution
- Worldwide distribution. US Nationwide, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Honduras, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakista
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0480-2019, Z-0483-2019, Z-0479-2019, Z-0481-2019, Z-0482-2019, Z-0484-2019
- Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
- Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
- Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
- Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
- Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
- Panda Wall Mount warmer. Infant radiant warmer
Terminated Class I Medical devices
- Recall started
- 14 September 2018
- Terminated
- 8 October 2020
- Reason
- A detector can detach and fall.
- Distribution
- United States: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,Guam,MA,MD,ME,MI,MO,MS,MT,NC,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR, RI,SC,SD,TN,TX,UT,VA,VT,WA,WI AND WV International: Albania, Argentina, Australia, Azerbaijan, Belgium, Bosnia ,Herzegovina, Brazil, Canada, Chile, China, Costa
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0371-2019, Z-0370-2019, Z-0369-2019
- GE Healthcare Millennium MC
- GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
- GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Terminated Class II Medical devices
- Recall started
- 14 September 2018
- Terminated
- 29 May 2019
- Reason
- There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AZ, IL, MA, ME, MN, MT, PA, TX, and WA and countries of: Foreign distribution was made to Austria, Denmark, Finland, and Norway.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0588-2019
- GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neo
Ongoing Class II Medical devices
- Recall started
- 11 September 2018
- Reason
- Patient monitors may restart due to network overload caused by network configuration.
- Distribution
- Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belgium, Bolivia, Bosnia-Herzegovina, Brazil, Brunei, Bulgaria, Burma (Myanmar), Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republ
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0583-2019, Z-0585-2019, Z-0586-2019, Z-0584-2019, Z-0587-2019
- PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological pa
- B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediat
- B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatr
- PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple ph
- B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patien
Ongoing Class II Medical devices
- Recall started
- 31 August 2018
- Reason
- The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
- Distribution
- Distribution was made nationwide, including Puerto Rico, Guam, and Samoa. There was also government and military distribution. Foreign distribution was made to Canada, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bo
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0521-2019, Z-0524-2019, Z-0523-2019, Z-0519-2019, Z-0520-2019, Z-0522-2019
- Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
- Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
- Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
- Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
- Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
- Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Terminated Class II Medical devices
- Recall started
- 30 August 2018
- Terminated
- 31 August 2022
- Reason
- Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.
- Distribution
- NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0195-2019
- Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
Ongoing Class II Medical devices
- Recall started
- 12 July 2018
- Reason
- On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator
- Distribution
- Worldwide Distribution - US (Nationwide Distribution) and countries of: Australia, Belgium, Canada, Estonia, Finland, France, Germany, Hong Kong, Ireland, Japan, Korea Republic of, Malaysia, Morocco, New Zealand, Norway, Saudi Arabia, Singapore, Slovakia, Sweden, Switzerland, Thailand, Turkey, Unite
- Initiated
- FDA Mandated
- Recall number
- Z-0776-2019
- Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Terminated Class II Medical devices
- Recall started
- 24 May 2018
- Terminated
- 8 February 2019
- Reason
- Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
- Distribution
- Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2583-2018, Z-2584-2018, Z-2579-2018, Z-2578-2018, Z-2585-2018, Z-2586-2018, Z-2582-2018, Z-2580-2018, Z-2581-2018, Z-2587-2018
- CT Goldseal Optima CT 600
- Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
- Discovery MI Digital Ready
- Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
- Optima CT 520
- Optima CT 540
- Revolution CT 160 1.5D STD WAUK
- Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
- and 2 more product lines
Completed Class II Medical devices
- Recall started
- 24 May 2018
- Reason
- When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard.
- Distribution
- CA, DC, OH, UT, WI, Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0606-2019, Z-0608-2019, Z-0607-2019
- Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limi
- Discovery NM/CT 670 Pro, model 5376204-70-54
- Discovery NM/CT 670 ES, model 5376204-70-57
Terminated Class II Medical devices
- Recall started
- 23 February 2018
- Terminated
- 30 September 2024
- Reason
- A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more image series (i.e. all images within an image set) may be missing from an exam without indication to the user. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series.
- Distribution
- Worldwide Distribution-US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1302-2018
- GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from vari
Terminated Class II Medical devices
- Recall started
- 25 January 2018
- Terminated
- 2 November 2023
- Reason
- Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, LA, MA, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OK, OR. PA. SD, TN, TX, UT, WA, WI, WV, and WY and the countries of Austria, Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, India, Irela
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2101-2018, Z-2102-2018
- Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images a
- Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can b
Terminated Class II Medical devices
- Recall started
- 15 December 2017
- Terminated
- 21 April 2020
- Reason
- if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).
- Distribution
- Worldwide - US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1293-2018, Z-1292-2018
- Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the
- Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to
Completed Class II Medical devices
- Recall started
- 30 October 2017
- Reason
- A potential hazardous situation may occur if the collimator locking handle is not properly placed in the lock position and the warning circuit does not detect that the collimator is unlocked because of the patient proximity to the collimator during a clinical scan.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0703-2019, Z-0704-2019
- Discover VH/Millennium VG Nuclear Medicine Imaging System
- VariCam
Terminated Class II Medical devices
- Recall started
- 4 October 2017
- Terminated
- 10 April 2020
- Reason
- Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
- Distribution
- US Distribution to states of: AZ, IL NC, NH and PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1199-2018, Z-1198-2018
- DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
- DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.
Terminated Class II Medical devices
- Recall started
- 16 September 2016
- Terminated
- 26 July 2018
- Reason
- The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes.
- Distribution
- AK, AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MS, NJ, NM, OR, PA, TN, TX, VA, and Guam, and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2523-2018
- Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
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.