Atlanta, GA, United States
Elekta, Inc. recalls
41 recalls recorded since 2018, most recently on 21 May 2026. 23 are listed as ongoing. Status and classification are as published by the FDA.
Recalls41
Ongoing (FDA)23
Terminated or completed18
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 May 2026
- Reason
- Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
- Distribution
- Worldwide - US Nationwide distribution in the states of WI, FL, LA, NY, NY, NJ, KS, FL, IA, NM, TX and the countries of Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Pakistan, Panama, Poland, Spain, Sweden,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2406-2026
- MOSAIQ Oncology Information System
Ongoing Class II Medical devices
- Recall started
- 3 April 2026
- Reason
- Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TX, UT, VA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivi
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2710-2026, Z-2711-2026, Z-2712-2026
- Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy
- Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of
- Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be plac
Ongoing Class II Medical devices
- Recall started
- 19 March 2026
- Reason
- Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
- Distribution
- US: AR AZ CA CO DC FL GA ID IL KS MA MD ME MO MT NC NE NH NJ NM NV NY OH OK PA SC TX UT VA WA WI WV OUS: Algeria Australia Austria Azerbaijan Belgium China Colombia Costa Rica Croatia Czech Republic Egypt Estonia Finland France Germany Greece Hong Kong Hungary India Israel Italy Japan Korea, Repub
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2006-2026
- Brand Name: Leksell Vantage Arc System REF: 1053958
Ongoing Class II Medical devices
- Recall started
- 18 February 2026
- Reason
- Due to adapter not being properly aligned or locked in place.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Austria, Belarus, Belgium, Braz
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1581-2026
- Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and
Ongoing Class II Medical devices
- Recall started
- 14 December 2025
- Reason
- Due to a manufacturing issue and electrical grounding of systems.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1164-2026
- Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No
Ongoing Class II Medical devices
- Recall started
- 12 December 2025
- Reason
- Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI, MN. MO, NC, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, Chin
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1340-2026, Z-1339-2026
- Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ t
- Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatme
Ongoing Class II Medical devices
- Recall started
- 10 December 2025
- Reason
- Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
- Distribution
- US Nationwide distribution in the state of TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1078-2026
- MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Ongoing Class II Medical devices
- Recall started
- 30 September 2025
- Reason
- Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of AR, CA, CO, FL, ID, IL, LA, MA, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. The countries of Algeria, Australia, Austria, Belgium, China, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, Finland, Fr
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0433-2026
- Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization
Ongoing Class II Medical devices
- Recall started
- 15 January 2025
- Reason
- Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
- Distribution
- US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina Brazil Canada France Germany Hong Kong Italy Japan Korea, Republic of Malta Netherlands Panama South Africa Spain Taiwan Thailand Turkey Venezuela
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1162-2025
- MOSAIQ Oncology Information System
Ongoing Class II Medical devices
- Recall started
- 25 October 2023
- Reason
- Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0446-2024, Z-0444-2024, Z-0445-2024, Z-0447-2024, Z-0443-2024, Z-0442-2024
- ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Ongoing Class II Medical devices
- Recall started
- 5 May 2023
- Reason
- A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
- Distribution
- Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA. International distribution to Belgium, Canada, Chile, China, France, Germany, India, Iraq, Italy, Jordan, Libyan Arab Jamahiriya, Mauritius, Mexico, Morocco, Poland, Russian Federation, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1665-2023
- Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Ongoing Class II Medical devices
- Recall started
- 6 April 2023
- Reason
- There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
- Distribution
- US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1675-2023
- Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Ongoing Class II Medical devices
- Recall started
- 28 February 2023
- Reason
- Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
- Distribution
- Nationwide distribution in the US. International distribution to Albania, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegowina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Curacao, Cyprus,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1233-2023
- Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Ongoing Class II Medical devices
- Recall started
- 5 December 2022
- Reason
- A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
- Distribution
- Distribution US nationwide, including Puerto Rico. There was no military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0719-2023
- Oncentra Brachy radiation therapy planning system software.
Ongoing Class II Medical devices
- Recall started
- 13 October 2021
- Reason
- Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
- Distribution
- Distribution throughout USA OUS distribution including:Algeria, Argentina, Australia, Austria Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, German
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0182-2022
- Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Terminated Class II Medical devices
- Recall started
- 17 September 2021
- Terminated
- 30 September 2024
- Reason
- There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
- Distribution
- Distributed nationwide to FL, NC, OH, CA, IL, MD, OR, AL, NY, PA, MA, AK, GA, OR, KY, VA, TX, SD, AZ, NJ, MI, WI, ND, MO, WA, OK, PR, NM, NC, ID, CT, DE, LA, MT, TN, CO, UT, MN, IN, RI, IA, DC, ND, AZ, HI, KS, NE, NH, AR, WY, WV, MS, VT and internationally to Albania, Antigua/Barbuda, Algeria, Arge
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0116-2022
- Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Synergy; d. Elekta Infinity; e. Versa HD
Ongoing Class II Medical devices
- Recall started
- 14 September 2021
- Reason
- Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of PA, MI, WI, NY, TN, NJ, IA, TX and the countries of United Kingdom, Turkey, Switzerland, Sweden, Spain, Netherlands, Korea, Thailand, Japan, Italy, Hong Kong, Germany, France, Denmark, China, Canada, Belgium, Bahrain, Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2563-2021
- Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Ongoing Class II Medical devices
- Recall started
- 2 September 2021
- Reason
- A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
- Distribution
- Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA. There was no military/government distribution. Foreign distribution was made to Australia, Canada, and the United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2591-2021
- MOSAIQ Oncology Information System
Ongoing Class II Medical devices
- Recall started
- 26 July 2021
- Reason
- If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
- Distribution
- Distribution in US - IA, NJ, NY, TN, PA, TX, and WI OUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2406-2021
- Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Terminated Class II Medical devices
- Recall started
- 20 April 2021
- Terminated
- 17 January 2023
- Reason
- Malware attack
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1783-2021
- Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Terminated Class II Medical devices
- Recall started
- 21 May 2020
- Terminated
- 19 August 2024
- Reason
- In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.
- Distribution
- US distribution to IA, NY, PA, TX, WI. International distribution to Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Turkey, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2297-2020
- Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Terminated Class II Medical devices
- Recall started
- 30 April 2020
- Terminated
- 4 August 2021
- Reason
- potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of PA, WI, NY, TN, NJ, IA, TX, and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2289-2020
- Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in th
Ongoing Class II Medical devices
- Recall started
- 16 April 2020
- Reason
- The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
- Distribution
- Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1825-2020
- Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
Terminated Class II Medical devices
- Recall started
- 30 March 2020
- Terminated
- 10 April 2024
- Reason
- A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.
- Distribution
- US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1826-2020
- Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Terminated Class II Medical devices
- Recall started
- 18 December 2019
- Terminated
- 15 June 2021
- Reason
- There have been reports of excessive heating in the MRL Gradient Connection Module.
- Distribution
- Distributed in US - PA, NY, and IA. Distributed ROW - Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, Netherlands, Sweden, Thailand, Turkey, UK. There was no government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2473-2020
- Elekta Unity, Image-Guided Radiation Therapy System
Ongoing Class II Medical devices
- Recall started
- 22 November 2019
- Reason
- Monaco is using the incorrect energy when optimizing and calculating dose.
- Distribution
- IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0670-2020
- Monaco Radiation Treatment Planning System (RTP) System
Ongoing Class II Medical devices
- Recall started
- 4 September 2019
- Reason
- It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
- Distribution
- Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2561-2019, Z-2560-2019
- Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calcu
- Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calc
Terminated Class II Medical devices
- Recall started
- 23 August 2019
- Terminated
- 28 June 2024
- Reason
- Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
- Distribution
- Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2409-2019
- Monaco Radiation Treatment Planning System (RTP) System
Ongoing Class II Medical devices
- Recall started
- 3 July 2019
- Reason
- When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2091-2019
- Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Terminated Class II Medical devices
- Recall started
- 24 June 2019
- Terminated
- 1 April 2021
- Reason
- The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.
- Distribution
- US Distribution to states of: TX & WI, and Internationally to: Canada, Denmark, Germany, Italy, Netherlands, Sweden, and the UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1980-2019
- Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases an
Terminated Class II Medical devices
- Recall started
- 19 June 2019
- Terminated
- 6 May 2024
- Reason
- Potential for iGUIDE to incorrectly monitor the 3D position.
- Distribution
- Nationwide distribution to AK, AL, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI. Worldwide distribution to Algeria, Argentina, Australia, Austria, Belgium, Botswana, Canada, Chile, China, Colombia, Cyprus, C
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2230-2019
- iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Terminated Class II Medical devices
- Recall started
- 3 April 2019
- Terminated
- 1 May 2023
- Reason
- There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.
- Distribution
- Worldwide Distribution - US Nationwide in the states of Texas and Wisconsin. Distribution internationally to Denmark, England, Germany, Italy, Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1297-2019
- Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the b
Terminated Class II Medical devices
- Recall started
- 12 March 2019
- Terminated
- 3 November 2023
- Reason
- Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
- Distribution
- Worldwide Distribution - US Nationwide in the states of TX, NY, WI, and Denmark, Germany, Italy, Netherlands, Sweden, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1109-2019
- Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and be
Terminated Class II Medical devices
- Recall started
- 8 February 2019
- Terminated
- 19 August 2024
- Reason
- If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.
- Distribution
- Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0965-2019
- Monaco Radiation Treatment Planning (RTP) System
Completed Class II Medical devices
- Recall started
- 4 January 2019
- Reason
- In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.
- Distribution
- TX and WI, Germany, Denmark, Netherlands, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0706-2019
Ongoing Class II Medical devices
- Recall started
- 13 December 2018
- Reason
- There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.
- Distribution
- U.S. Nationwide distribution to the following states AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the District of Columbia and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0821-2019
- MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel
Terminated Class II Medical devices
- Recall started
- 4 December 2018
- Terminated
- 23 February 2026
- Reason
- If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.
- Distribution
- Distributed in the United States and outside of the Unites States: Algeria; Antigua and Barbuda; Argentina; Australia; Belgium; Botswana; Brazil; Canada; China; Colombia; Denmark; France; Germany; India; Indonesia; Iran; Ireland; Israel; Italy; Japan; Latvia; Lebanon; Malaysia; Mexico; Morocco; Myan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0686-2019
- MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
Terminated Class II Medical devices
- Recall started
- 3 August 2018
- Terminated
- 23 September 2024
- Reason
- Order Status Remains Approved When Should Indicate Complete.
- Distribution
- AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, WA, WI, WV, and WY Australia, Canada, Ireland, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2917-2018
- MOSAIQ Oncology Information System
Terminated Class II Medical devices
- Recall started
- 16 May 2018
- Terminated
- 30 October 2020
- Reason
- Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting in incorrect patient positioning.
- Distribution
- Worldwide Distribution - US Distribution of the device was made nationwide. There was government distribution but no military distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Chile, China, Colombia, Czech Repu
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2535-2018
- HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy
Terminated Class II Medical devices
- Recall started
- 1 December 2017
- Terminated
- 5 November 2019
- Reason
- There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, 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, VT, WA, WI, WV, WY, Alaska, District of Columbia, Hawaii and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2840-2018
- ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD
Terminated Class II Medical devices
- Recall started
- 20 November 2017
- Terminated
- 15 March 2024
- Reason
- Potential for positional errors following automatic table movement (ATM).
- Distribution
- Distributed domestically to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to ALBANIA, ALGERIA, ANTIGUA AND BARBUDA, ARGEN
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0724-2018, Z-0723-2018
- Integrity R1.2
- Agility with Integrity R3.2
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.