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Browse Device Recalls

708 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 708 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 708 FDA device recalls.

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DateProductReasonClassFirm
May 7, 2012 The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended ... Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems cur... Class II Philips Medical Systems (Cleveland) Inc
Sep 1, 2011 The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems inte... During a Field Test (a customer external evaluation period), the customer detected a problem in t... Class II Philips Medical Systems (Cleveland) Inc
Mar 7, 2011 Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, ... The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a re... Class II Philips Medical Systems (Cleveland) Inc
Mar 3, 2011 Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running ... Multiple software defects which could impact the performance or reliability of the system. These... Class II Philips Medical Systems (Cleveland) Inc
May 1, 2008 GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile install... The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT s... Class II Philips Medical Systems (Cleveland) Inc
Jan 9, 2007 No packaging. The device is a computed tomography scanner. Intended to ... When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in te... Class II Philips Medical Systems (Cleveland) Inc
Apr 25, 2006 Brilliance CT (computed tomography) scanners, Big Bore configuration, Model n... Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization appli... Class II Philips Medical Systems (Cleveland) Inc
Dec 27, 2005 Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as sin... The system has a gap that can appear between the upper and lower tilt stand covers. The fingers m... 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.