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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 11 FDA device recalls.

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DateProductReasonClassFirm
Oct 25, 2023 ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical C... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Partic... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiati... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charg... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
Oct 25, 2023 ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; M... Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there i... Class II Elekta, Inc.
May 21, 2020 Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, ... In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there ca... Class II Elekta Limited
Apr 3, 2019 Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance... There is no warning in the Elekta Unity manual for the administration of gadolinium-based or othe... Class II Elekta Limited
Mar 12, 2019 Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta... Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The... Class II Elekta Limited
Jan 4, 2019 Elekta Unity In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water lea... Class II Elekta Limited
Nov 20, 2017 Agility with Integrity R3.2 Potential for positional errors following automatic table movement (ATM). Class II Elekta Limited
Nov 20, 2017 Integrity R1.2 Potential for positional errors following automatic table movement (ATM). Class II Elekta Limited

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.