Browse Device Recalls

685 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 685 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 685 FDA device recalls.

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DateProductReasonClassFirm
Jan 21, 2013 Ingenuity TF PET/CT. Diagnostic imaging system The system may not default to the same gating trigger with which the data were acquired. This cou... Class II Philips Medical Systems (Cleveland) Inc
Dec 20, 2012 Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and ... Philips Healthcare received reports from the field stating the patient table on a system had an u... 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
Dec 19, 2012 Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray... The four screws that secure the patient table top to the carrier became loose, which caused the t... Class II Philips Medical Systems (Cleveland) Inc
Dec 3, 2012 Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: B... Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0x... Class II Philips Medical Systems (Cleveland) Inc
Oct 24, 2012 Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #88... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 24, 2012 Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 24, 2012 Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, ... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 24, 2012 Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, ... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... 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.
Sep 28, 2012 Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model ... Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to s... Class II Philips Medical Systems (Cleveland) Inc
Sep 28, 2012 Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomograp... Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the E... Class II Philips Medical Systems (Cleveland) Inc
Sep 18, 2012 Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips... The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents th... Class II Philips Medical Systems (Cleveland) Inc
Sep 11, 2012 Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 P... Philips was notified that when performing post processing with the Brilliance Workspace Portal pl... Class II Philips Medical Systems (Cleveland) Inc
Aug 31, 2012 The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system i... Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causin... Class II Philips Medical Systems (Cleveland) Inc
Aug 28, 2012 The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole B... Philips was notified that the system logout in software version 2.3.6 is now longer and may somet... Class III Philips Medical Systems (Cleveland) Inc
Aug 24, 2012 MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT S... On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches... Class II Philips Medical Systems (Cleveland) Inc
Aug 21, 2012 Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual ... A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumu... Class II Philips Medical Systems (Cleveland) Inc
Aug 8, 2012 Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 1... Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a... Class II Philips Medical Systems (Cleveland) Inc
Aug 3, 2012 The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ra... The patient support may move in an unintended manner if the foot switch cover becomes damaged and... Class II Philips Medical Systems (Cleveland) Inc
Jul 26, 2012 Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model numbe... Philips determined that it is important to clarify information in the Owner's Manual and keep cus... Class II Philips Medical Systems North America Co. Phi...
Jul 26, 2012 Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured b... Philips determined that it is important to clarify information in the Owner's Manual and keep cus... Class II Philips Medical Systems North America Co. Phi...
Jul 18, 2012 The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray S... 1. The current system design of software version 4.0.0xx379 does not prevent the system from scan... Class II Philips Medical Systems (Cleveland) Inc
Jul 2, 2012 Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomog... Philips Healthcare was notified that several of the sixteen bolts securing the brackets which sup... Class II Philips Medical Systems (Cleveland) Inc
May 23, 2012 Intellispace Portal software. Intellispace Portal is a multimodality thin ... Philips is issuing a software update to the Intellispace Portal systems to address a number of no... Class II Philips Medical Systems (Cleveland) Inc
May 23, 2012 IntelliSpace Portal software and Extended Brillance Workspace software In... The Intellispace Portal software and Extended Brillance Workspace software may have significantly... Class II Philips Medical Systems (Cleveland) Inc
May 22, 2012 Intellispace Portal software Product Usage: Intellispace Portal is a mult... In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using ... Class II Philips Medical Systems (Cleveland) Inc
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.