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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.