Browse Device Recalls
446 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 446 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 446 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 9, 2023 | Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 | When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the ope... | Class II | Philips North America |
| Oct 9, 2023 | Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner ... | For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... | Class II | Philips North America Llc |
| Oct 9, 2023 | Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT... | For oncology users: If the user performed off-set reconstruction on CT device a shift could be ob... | Class II | Philips North America Llc |
| Oct 9, 2023 | Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 | This recall is part of a 2-issue recall for the same system. When using the IVC needle position b... | Class II | Philips North America |
| Oct 4, 2023 | Integris-Allura IGTS Fixed Systems | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | Azurion IGTS Fixed Systems | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | Zenition 50 & 70 Mobile Surgery C-arm | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | Veradius Unity Mobile Surgery C-arm | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surge... | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | Allura Xper IGTS Fixed Systems | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Sep 21, 2023 | DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and ex... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display a... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, dis... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost C90 High Performance, used to acquire, process, store, displa... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost C90 Release 3, used to acquire, process, store, display and e... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost 4 High Performance, used to acquire, process, store, display ... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display a... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Aug 31, 2023 | EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidest... | A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... | Class II | Philips North America Llc |
| Aug 31, 2023 | EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream e... | A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... | Class II | Philips North America Llc |
| Aug 17, 2023 | Patient Information Center iX with Software Version Number 4.x in the followi... | Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driv... | Class II | Philips North America Llc |
| Jun 14, 2023 | IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01... | Devices with Option CP2 and initially programmed to software version P.01.01 were configured inco... | Class II | Philips North America Llc |
| Jun 12, 2023 | Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and ... | During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector... | Class II | Philips North America |
| Jun 12, 2023 | Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and ... | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after ... | Class II | Philips North America |
| Jun 12, 2023 | MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Up... | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after ... | Class II | Philips North America |
| Jun 12, 2023 | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782... | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after ... | Class II | Philips North America |
| Jun 12, 2023 | MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Up... | During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector... | Class II | Philips North America |
| Jun 12, 2023 | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782... | During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector... | Class II | Philips North America |
| May 19, 2023 | DigitalDiagnost C90, Model No. 712034 and 712035 | There is a software login in issue that may prevent the user from logging in. | Class II | Philips North America Llc |
| Apr 25, 2023 | Incisive CT Plus-Computed Tomography X-Ray System Model: 728149 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | Incisive CT-Computed Tomography X-Ray System Model: 728143 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 19, 2023 | Patient Information Center iX, Product Code 866386, and Patient Information C... | During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Proto... | Class II | Philips North America |
| Mar 20, 2023 | Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814 | Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot swi... | Class II | Philips North America |
| Mar 20, 2023 | Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813 | Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot swi... | Class II | Philips North America |
| Mar 17, 2023 | Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 | Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment ... | Class II | Philips North America Llc |
| Mar 9, 2023 | DigitalDiagnost C50 1.1-intended for use in generating radiographic images of... | If the PM for the telescopic carriage is not performed annually as defined in the Instructions fo... | Class II | Philips North America Llc |
| Mar 9, 2023 | Philips DigitalDiagnost C50 -intended for use in generating radiographic imag... | If the PM for the telescopic carriage is not performed annually as defined in the Instructions fo... | Class II | Philips North America Llc |
| Mar 6, 2023 | EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Pr... | EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r... | Class II | Philips North America Llc |
| Mar 6, 2023 | EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Produ... | EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r... | Class II | Philips North America Llc |
| Mar 3, 2023 | CombiDiagnost R90 R1.1 | Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... | Class II | Philips North America |
| Mar 3, 2023 | CombiDiagnost R90 R.1.0 | Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... | Class II | Philips North America |
| Mar 3, 2023 | ProxiDiagnost N90 R.1.0 | Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... | Class II | Philips North America |
| Jan 18, 2023 | IntelliVue G7m Anesthesia Gas Module, Product Number 866173 | The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an... | Class II | Philips North America |
| Nov 22, 2022 | Philips Upgrade to MR 7700 System, Model Number 782130 | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 78... | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
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.