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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 6, 2014 Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical System... A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions wo... Class II Philips Medical Systems (Cleveland) Inc
Feb 11, 2014 Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. Philips Medical Systems have recently determined that a software nonconformance can cause incorre... Class II Philips Medical Systems (Cleveland), Inc.
Mar 12, 2013 Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Wat... Philips Healthcare received a report from the field stating when they viewed the CTDIVol informat... Class II Philips Medical Systems (Cleveland) Inc
Feb 12, 2013 Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., Intel... Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with ... Class II Philips Medical Systems (Cleveland) Inc
Dec 20, 2012 Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emis... Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605... Class II Philips Medical Systems (Cleveland) Inc
Oct 5, 2012 Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), ... Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection softwa... Class II Philips Medical Systems (Cleveland), 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.