Browse Device Recalls

313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 313 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 313 FDA device recalls.

Clear
DateProductReasonClassFirm
Mar 24, 2016 Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to p... Software defect causing intermittently slow response of Host. Class II Philips Medical Systems (Cleveland) Inc
Mar 24, 2016 Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce c... Software defect causing intermittently slow response of Host. Class II Philips Medical Systems (Cleveland) Inc
Mar 24, 2016 Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to pr... Software defect causing intermittently slow response of Host. Class II Philips Medical Systems (Cleveland) Inc
Mar 24, 2016 Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-... Software defect causing intermittently slow response of Host. Class II Philips Medical Systems (Cleveland) Inc
Mar 4, 2016 Extended Brilliance Workspace NM Nuclear medicine image display and processin... The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with d... Class II Philips Medical Systems (Cleveland) Inc
Mar 4, 2016 Extended Brilliance Workspace NM Special Nuclear medicine image display and p... The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with d... Class II Philips Medical Systems (Cleveland) Inc
Mar 4, 2016 IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medi... The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with d... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2016 Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-... The firm was notified of a software error in which the system may not automatically send all imag... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2016 Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cros... The firm was notified of a software error in which the system may not automatically send all imag... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2016 Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cr... The firm was notified of a software error in which the system may not automatically send all imag... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2016 Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-s... The firm was notified of a software error in which the system may not automatically send all imag... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2016 Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-se... The firm was notified of a software error in which the system may not automatically send all imag... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2016 Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cro... The firm was notified of a software error in which the system may not automatically send all imag... Class II Philips Medical Systems (Cleveland) Inc
Dec 17, 2015 BrightView X are gamma cameras; Designed for single or dual detector nuclear ... The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardia... Class II Philips Medical Systems (Cleveland) Inc
Dec 17, 2015 BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emi... The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardia... Class II Philips Medical Systems (Cleveland) Inc
Dec 17, 2015 BrightView are gamma cameras; Designed for single or dual detector nuclear im... The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardia... Class II Philips Medical Systems (Cleveland) Inc
Oct 29, 2015 Brilliance 64 Computed Tomography X-ray system Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... Class II Philips Medical Systems (Cleveland) Inc
Oct 29, 2015 Brilliance iCT SP Computed Tomography X-ray system Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... Class II Philips Medical Systems (Cleveland) Inc
Oct 29, 2015 Ingenuity Core Computed Tomography X-ray system Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... Class II Philips Medical Systems (Cleveland) Inc
Oct 29, 2015 Ingenuity Core 128 Computed Tomography X-ray system Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... Class II Philips Medical Systems (Cleveland) Inc
Oct 29, 2015 Brilliance iCT Computed Tomography X-ray system Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... Class II Philips Medical Systems (Cleveland) Inc
Oct 29, 2015 Ingenuity CT Computed Tomography X-ray system Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... Class II Philips Medical Systems (Cleveland) Inc
Sep 14, 2015 Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce c... The firm discovered Ring/Dot artifact due to X-ray measurement error. Class II Philips Medical Systems (Cleveland) Inc
Sep 14, 2015 Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross... The firm discovered Ring/Dot artifact due to X-ray measurement error. Class II Philips Medical Systems (Cleveland) Inc
Sep 14, 2015 Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems.... The firm discovered Ring/Dot artifact due to X-ray measurement error. Class II Philips Medical Systems (Cleveland) Inc
Sep 14, 2015 Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to pro... The firm discovered Ring/Dot artifact due to X-ray measurement error. Class II Philips Medical Systems (Cleveland) Inc
Sep 14, 2015 Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-... The firm discovered Ring/Dot artifact due to X-ray measurement error. Class II Philips Medical Systems (Cleveland) Inc
Sep 14, 2015 Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-s... The firm discovered Ring/Dot artifact due to X-ray measurement error. Class II Philips Medical Systems (Cleveland) Inc
Jul 23, 2015 Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruct... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems ar... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a ... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems a... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging System... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Syste... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging System... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Jul 1, 2015 GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging System... Philips has identified four (4) software defects in the Tumor LOC software application that may p... Class II Philips Medical Systems (Cleveland) Inc
Apr 13, 2015 Brilliance iCT Computed Tomography X-ray system A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of ... Class II Philips Medical Systems (Cleveland) Inc
Mar 17, 2015 Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems... A head holder released for use with other CT systems but not yet qualified for use on the Ingenui... Class II Philips Medical Systems (Cleveland) Inc
Mar 17, 2015 Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems A head holder released for use with other CT systems but not yet qualified for use on the Ingenui... Class II Philips Medical Systems (Cleveland) Inc
Mar 17, 2015 Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. ... A head holder released for use with other CT systems but not yet qualified for use on the Ingenui... Class II Philips Medical Systems (Cleveland) Inc
Mar 16, 2015 Brilliance CT 40. Computed Tomography X-ray systems intended to produce cr... The firm was informed that while raising the patient couch on the system to perform an exam, the ... Class II Philips Medical Systems (Cleveland) Inc
Mar 16, 2015 MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to p... The firm was informed that while raising the patient couch on the system to perform an exam, the ... Class II Philips Medical Systems (Cleveland) Inc
Mar 16, 2015 Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-... The firm was informed that while raising the patient couch on the system to perform an exam, the ... Class II Philips Medical Systems (Cleveland) Inc
Mar 16, 2015 Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intende... The firm was informed that while raising the patient couch on the system to perform an exam, the ... Class II Philips Medical Systems (Cleveland) Inc
Mar 16, 2015 Brilliance CT 64. Computed Tomography X-ray systems intended to produce cr... The firm was informed that while raising the patient couch on the system to perform an exam, the ... Class II Philips Medical Systems (Cleveland) Inc
Mar 16, 2015 Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce... The firm was informed that while raising the patient couch on the system to perform an exam, the ... Class II Philips Medical Systems (Cleveland) Inc
Mar 16, 2015 Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produc... The firm was informed that while raising the patient couch on the system to perform an exam, the ... Class II Philips Medical Systems (Cleveland) Inc
Mar 16, 2015 Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produc... The firm was informed that while raising the patient couch on the system to perform an exam, the ... Class II Philips Medical Systems (Cleveland) Inc
Mar 16, 2015 Brilliance CT 16 Power. Computed Tomography X-ray systems intended to prod... The firm was informed that while raising the patient couch on the system to perform an exam, the ... Class II Philips Medical Systems (Cleveland) Inc
Mar 16, 2015 Brilliance iCT. Computed Tomography X-ray systems intended to produce cros... The firm was informed that while raising the patient couch on the system to perform an exam, the ... 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.