Browse Device Recalls
725 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 725 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 725 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 13, 2025 | Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025. | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028. | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura CV20 System Code: 722031 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221. | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 72228... | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura CV20; Catalog numbers: 722031 | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY). | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013. | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 3 M12 System Code: (1) 722063 (2) 722221 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Nov 11, 2024 | Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. All... | Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Oct 10, 2024 | Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software... | A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calc... | Class II | Philips Medical Systems Technologies Ltd. |
| Oct 7, 2024 | Philips Zenition 70, Model Number: 718133 | Potential for the Mains Control Unit board fuse may blow out during system start-up or during a p... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Oct 7, 2024 | Philips Zenition 50, Model Number: 718096 | Potential for the Mains Control Unit board fuse may blow out during system start-up or during a p... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 22, 2024 | System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagno... | Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Res... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 22, 2024 | System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 7... | Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Res... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 22, 2024 | System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-... | Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Res... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 22, 2024 | System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 ... | Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Res... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 8, 2024 | Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluorosco... | A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt. | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 6, 2024 | Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventio... | The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eve... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jul 15, 2024 | Philips Azurion Interventional Fluoroscopic X-ray System with Software Versio... | Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| May 16, 2024 | Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: ... | When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| May 16, 2024 | Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model ... | When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| May 16, 2024 | Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: ... | When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| May 2, 2024 | Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Softw... | Potential for pressure wave data synchronization from two devices may not be correct. | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 4, 2024 | Philips IntelliSpace Cardiovascular software, Model 830089. | Study data is not able to be archived, copied, or exported with the cardiovascular software version. | Class II | Philips Medical Systems Nederland B.V. |
| Feb 6, 2024 | Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, ... | Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Feb 6, 2024 | Azurion 3 with a Certeray generator -To perform image guidance in diagnostic,... | Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Feb 6, 2024 | Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, ... | Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 2, 2024 | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... | Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 2, 2024 | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... | Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 2, 2024 | Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the D... | Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 2, 2024 | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... | Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 2, 2024 | Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the D... | Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 13, 2023 | Spectral CT on Rails: Software Version 5.1.0.X, model 728334. | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... | Class II | PHILIPS MEDICAL SYSTEMS |
| Dec 13, 2023 | Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 Chi... | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... | Class II | PHILIPS MEDICAL SYSTEMS |
| Dec 12, 2023 | Philips Azurion system, Interventional fluoroscopic x-ray system. System P... | System may exhibit a loss of imaging functionality and data due to an issue which can cause the s... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 8, 2023 | Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... | Loss of connectivity between the FlexArm and the Table due to a software issue related to the dat... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 8, 2023 | Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table... | Loss of connectivity between the FlexArm and the Table due to a software issue. | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 7, 2023 | Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2... | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Nov 3, 2023 | Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura X... | Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
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.