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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Mar 7, 2016 VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Ac... In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the fi... Class II MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...
Dec 15, 2015 MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Inte... Due to Operator Console software anomaly, a change in treatment completion status of the last pat... Class II MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...
Apr 17, 2015 MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) The operator console allows users to deliver therapeutic radiation to patients even though a spec... Class II MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...
Dec 2, 2014 VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-... Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (Ex... Class II MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...
Jul 5, 2014 VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medica... Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, t... Class II MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...
Jun 21, 2013 MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or e... Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue asso... Class II MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...

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.