Browse Device Recalls
477 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 477 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 477 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 28, 2026 | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dS... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R1... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S),... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... | Class II | Philips North America |
| Aug 28, 2026 | SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software V... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; So... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 a... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 78... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. ... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... | Class II | Philips North America |
| Aug 28, 2026 | MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; So... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... | Class II | Philips North America |
| Aug 21, 2026 | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dS... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Int... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 7... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 7... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253; | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 78... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | MR 5300 Model Number (REF): 1. 782110, 2. 782152; | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3.... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), ... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 78134... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 18, 2026 | Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x,... | The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots ma... | Class II | Philips North America Llc |
| Aug 7, 2026 | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brillian... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Aug 7, 2026 | Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spe... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Aug 7, 2026 | Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuit... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Aug 7, 2026 | Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Bril... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Jul 31, 2026 | Philips Patient Information Center iX REF:866389 | Due to software malfunction, patient information system may freeze and become unresponsive. | Class II | Philips North America |
| Jul 31, 2026 | Philips PIC iX Essentials REF:867093 | Due to software malfunction, patient information system may freeze and become unresponsive. | Class II | Philips North America |
| Jul 1, 2026 | Cardiac Workstation 7000. Product Number: 860441. | Device will intermittently provide inaccurate data related to native heart rate. | Class II | Philips North America Llc |
| Jul 1, 2026 | Cardiac Workstation 5000. Product Number: 860439. | Device will intermittently provide inaccurate data related to native heart rate. | Class II | Philips North America Llc |
| Jun 5, 2026 | Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the fo... | Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device c... | Class II | Philips North America Llc |
| May 26, 2026 | Philips Avalon Fetal Monitor, FM 30 Part numberM2703A | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulle... | Class II | Philips North America Llc |
| May 26, 2026 | Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulle... | Class II | Philips North America Llc |
| May 1, 2026 | DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. | System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to pr... | Class II | Philips North America Llc |
| Apr 14, 2026 | Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Mode... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). ... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (R... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (R... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (RE... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Numbe... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model ... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF)... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (RE... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF)... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
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.