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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
May 4, 2021 ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product ... Software anomalies affecting the French, German and Italian versions of treatment delivery system... Class II Viewray, Inc.
Oct 20, 2020 ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 38... There is a potential that components of the receive coil can reach elevated temperatures which ha... Class II Viewray, Inc.
Oct 20, 2020 ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 ... There is a potential that components of the receive coil can reach elevated temperatures which ha... Class II Viewray, Inc.
Nov 18, 2019 ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 ... Registering dose and structures in the treatment delivery workflow could result in an alignment d... Class II Viewray, Inc.
Mar 18, 2019 MRIdian Linac Radiation Therapy System, Model 20000. A discrepancy between optimization and planning forward dose calculation between adaptive optimiz... Class II Viewray, Inc.
Mar 3, 2019 MRIdian Linac Radiation Therapy System Model 10000 and 20000 Issue with transferring treatment regiment from one system to another. Adequate instructions for... Class II Viewray, Inc.

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.