| Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K1 recall (Z-2632-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-25 |
| Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K1 recall (Z-2633-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-25 |
| Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K1 recall (Z-2634-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-25 |
| Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K recall (Z-2635-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-25 |
| IntelliSpace Cardiovascular, Software 8.0.0.4. recall (Z-2543-2025) | Philips Medical Systems Nederland B.V. | 2025-09-09 |
| Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled recall (Z-2502-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-03 |
| Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled a recall (Z-2503-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-03 |
| Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the foll recall (Z-2504-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-03 |
| Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: recall (Z-2189-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-07-29 |
| Azurion 7 M20. Fluoroscopic X-Ray System. recall (Z-2134-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-07-18 |
| Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 7220 recall (Z-1969-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-06-12 |
| Enterprise 1.5T, Model Number: 781145; recall (Z-1770-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| Intera 0.5T Standard, Model Number: 781101; recall (Z-1771-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| Intera 1.0T Omni/Stellar, Model Number: 781102; recall (Z-1772-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| Intera 1.0T Power/Pulsar, Model Number: 781103; recall (Z-1773-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| Intera 1.5T, Model Numbers: 781195 and 781295; recall (Z-1774-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| Intera 1.5T Explorer/Nova Dual, Model Number: 781108; recall (Z-1775-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| Intera 1.5T Master/Nova, Model Number: 781106; recall (Z-1776-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| Intera 1.5T Omni/Stellar, Model Number: 781104; recall (Z-1777-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| Intera 1.5T Power/Pulsar, Model Number: 781105; recall (Z-1778-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| Intera 1.5T R11, Model Number: 781170; recall (Z-1779-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| Intera 3.0T Quasar Dual, Model Number: 781150; recall (Z-1780-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| Intera CV, Model Number: 781107; recall (Z-1781-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| SmartPath to dStream for 1.5T, Model Number: 782146; recall (Z-1782-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| SmartPath to dStream for 3.0T, Model Number: 782145; recall (Z-1783-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-05-15 |
| IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089. recall (Z-1740-2025) | Philips Medical Systems Nederland B.V. | 2025-05-08 |
| Zenition 70. The device is to be used in health care facilities both inside and outside th recall (Z-1583-2025) | Philips Medical Systems Nederland B.V. | 2025-04-21 |
| Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334; recall (Z-1324-2025) | Philips Medical Systems Nederland B.V. | 2025-03-12 |
| Philips IntelliSpace Cardiovascular software, Model 830089. recall (Z-1252-2025) | Philips Medical Systems Nederland B.V. | 2025-02-28 |
| Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026, recall (Z-1142-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027. recall (Z-1143-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028. recall (Z-1144-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013. recall (Z-1145-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025. recall (Z-1146-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035. recall (Z-1147-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Allura Xper FD20/10; Catalog numbers: 722029 recall (Z-1148-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Allura Xper FD20/15; Catalog numbers: 722058 recall (Z-1149-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Allura Xper FD20/20; Catalog numbers: 722038 recall (Z-1150-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Allura CV20; Catalog numbers: 722031 recall (Z-1151-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Allura Xper FD10C; Catalog number: 722001 recall (Z-1152-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221. recall (Z-1153-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY). recall (Z-1154-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY). recall (Z-1155-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY). recall (Z-1156-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY). recall (Z-1157-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236. recall (Z-1158-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY). recall (Z-1159-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY); recall (Z-1160-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). recall (Z-1161-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-20 |
| Allura CV20 System Code: 722031 recall (Z-1076-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026 recall (Z-1077-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027 recall (Z-1078-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| Allura Xper FD10C System Code: (1) 722001 recall (Z-1079-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028 recall (Z-1080-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013 recall (Z-1081-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025 recall (Z-1082-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035 recall (Z-1083-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| AlluraXperFD20/10 System Code: (1) 722029 recall (Z-1084-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| Allura Xper FD20/20 System Code: (1) 722038 recall (Z-1085-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| AlluraXperFD20/15 System Code: (1) 722058 recall (Z-1086-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| Azurion 3 M12 System Code: (1) 722063 (2) 722221 recall (Z-1087-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280 recall (Z-1088-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| Azurion 5 M12 System Code: (1) 722227 (2) 722231 recall (Z-1089-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281 recall (Z-1090-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235 recall (Z-1091-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236 recall (Z-1092-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233 recall (Z-1093-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 72 recall (Z-1094-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-02-04 |
| Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Mo recall (Z-0676-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-12-12 |
| Philips Zenition 50, Model Number: 718096 recall (Z-0352-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-11-12 |
| Philips Zenition 70, Model Number: 718133 recall (Z-0353-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-11-12 |
| Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. recall (Z-1647-2023) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-09-30 |
| System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Az recall (Z-3165-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-09-18 |
| System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura recall (Z-3166-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-09-18 |
| System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Vis recall (Z-3167-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-09-18 |
| System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with recall (Z-3168-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-09-18 |
| Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluorosco recall (Z-2953-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-09-04 |
| Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray Sys recall (Z-2716-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-08-22 |
| Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1. recall (Z-2534-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-08-08 |
| Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enab recall (Z-1926-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-05-30 |
| Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Softwa recall (Z-1895-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-05-24 |
| Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Softwa recall (Z-1896-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-05-24 |
| Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013 recall (Z-1897-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-05-24 |
| Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, intervention recall (Z-1176-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-02-22 |
| Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventiona recall (Z-1177-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-02-22 |
| Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventiona recall (Z-1178-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-02-22 |
| Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay o recall (Z-1144-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-02-16 |
| Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of th recall (Z-1145-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-02-16 |
| Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay o recall (Z-1151-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-02-16 |
| Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of th recall (Z-1152-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-02-16 |
| Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dua recall (Z-1156-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-02-16 |
| Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software ve recall (Z-0860-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-01-30 |
| Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software ve recall (Z-0861-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-01-30 |
| Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Mo recall (Z-0835-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2024-01-26 |
| Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 72200 recall (Z-0558-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2023-12-15 |
| Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 A recall (Z-0559-2024) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2023-12-15 |
| Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-E recall (Z-2587-2023) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2023-09-14 |
| Allura Xper series recall (Z-2402-2023) | Philips Medical Systems Nederland B.V. | 2023-09-07 |
| Azurion recall (Z-2403-2023) | Philips Medical Systems Nederland B.V. | 2023-09-07 |
| MultiDiagnost-Eleva recall (Z-2404-2023) | Philips Medical Systems Nederland B.V. | 2023-09-07 |