Browse Device Recalls
421 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 421 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 421 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Big Bore RT, Model Number:... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Nu... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance iCT, Model Numb... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Jun 30, 2025 | Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | MR 7700 Model Numbers (REF): (1) 782120, (2) 782153; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 78... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 78... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Intera 3.0T Quasar Dual Model Number (REF): 781150; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Upgrade to MR 7700 Model Number (REF): 782130; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) ... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia 1.5T S Model Number (REF): 781347; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | SmartPath to dStream for 3.0T Model Number (REF): 782145; | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| Jun 30, 2025 | Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (... | The potential for component failures in the Gradient Coil of the affected MR systems may act as a... | Class II | Philips North America |
| May 29, 2025 | Achieva XR Product Numbers: (1) 781153, (2) 781253; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Omni/Stellar; Product Number: 781104; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Master/Nova Product Number: 781106; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera Achieva 1.5T Pulsar; Product Number: 781171; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Achieva Nova Product Number: 781172; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Achieva IT Nova Product Number: 781175 | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | SmartPath to dStream for 1.5T¿; Product Number: 782146; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Explorer/Nova Dual Product Number: 781108; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Achieva Nova-Dual Product Number: 781173; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Spectral CT. Computed tomography X-ray system. | Devices with affected software may experience two unintended motion issues that may lead to conta... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Upgrade to MR 7700; Model Number: 782130; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 78139... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) ... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 78127... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3)... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2)... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) ... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3)... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: SmartPath to dStream for 3.0T; Model Number: 782145 | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia 1.5T S; Model Number: 781347; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) ... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | 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.