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 16, 2015 | Brilliance CT 16 Water. 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 13, 2015 | Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, AD... | During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 11, 2015 | Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imagin... | It was noticed that the spectroscopy voxel map did not align with the anatomical images of the ph... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 11, 2015 | Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC ... | The firm was notified by a customer that the collimator exchange carriage and the collimator stor... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devi... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Com... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogr... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supp... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Com... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Comput... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessor... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomograp... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory device... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory device... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Compu... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accesso... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogra... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) C... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Comp... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Com... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) C... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) C... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed T... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce ... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce c... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technol... | Philips discovered that a software defect exists in marketed product wherein the sign indication ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cros... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produ... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. ... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence techn... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 8, 2014 | Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit ... | Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion. | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2014 | BrightView model number: 882478 BrightView X model number: 882480 BrightVie... | Unintended detector and gantry movement due to software issues. | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 9, 2014 | IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/... | Software defect. In certain circumstances, the application may display incorrect measurements of... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 4, 2014 | BrightView product code: 882478 BrightView X product code: 882480 BrightVie... | Software issues | 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.