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 |
|---|---|---|---|---|
| Jun 5, 2024 | SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen ... | Potential for coils to heat up and harm patients (burn). | Class I | Philips North America Llc |
| May 22, 2024 | Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the f... | Potential for inaccurate fetal heart rate measurements when monitoring multiples. | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Sys... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 3.0T TX for PET Model Number (REF): 781479 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems ind... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 1.5T S Model Number (REF): 781347 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Med... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Syst... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical El... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems ... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Sy... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indica... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 1.5T Initial system Model Number (REF): 781178 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems i... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | HA FlexTrak-Patient transport functionality to transport the patient from the... | Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resu... | Class II | Philips North America Llc |
| May 3, 2024 | MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical System... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indi... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electric... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | HA FlexTrak-Patient transport functionality to transport the patient from the... | Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resu... | Class II | Philips North America Llc |
| May 3, 2024 | Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to dStream for 3.0T Model Number (REF): 782145 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Sy... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 78210... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrica... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | HA FlexTrak II-Patient transport functionality to transport the patient from ... | Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resu... | Class II | Philips North America Llc |
| May 3, 2024 | Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| Apr 22, 2024 | Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems ... | Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilatio... | Class II | Philips North America Llc |
| Apr 22, 2024 | Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems ar... | Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilatio... | Class II | Philips North America Llc |
| Apr 19, 2024 | Patient Information Center iX and Patient Information Center iX Expand, Softw... | Event Catalog information does not save when copied and transferred from one unit to another. | Class II | Philips North America Llc |
| Apr 15, 2024 | Incisive CT - Computed Tomography X-Ray System intended to produce cross-sect... | Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive... | Class II | Philips North America Llc |
| Apr 15, 2024 | Incisive CT - Computed Tomography X-Ray System intended to produce cross-sect... | Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive... | Class II | Philips North America Llc |
| Mar 29, 2024 | The Oncology Essentials Package of the Spectral CT imaging system. | Potential for third party oncology marking laser to be reflected off the gantry cover surface, wh... | Class II | Philips North America Llc |
| Mar 22, 2024 | Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS... | Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information... | Class II | Philips North America Llc |
| Mar 12, 2024 | Ingenia 3.0T CX, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 1.5T Master/Nova, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Ingenia Ambition S, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Ingenia 3.0T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 3.0T Quasar Dual, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | GYROSCAN T10-NT, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Ingenia 1.5T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | SmartPath to dStream for XR and 3.0T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | 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.