| Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722 recall (Z-2928-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-08-10 |
| Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722 recall (Z-2931-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-08-10 |
| Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, an recall (Z-2932-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-08-10 |
| Philips Allura under the following System Descriptions and corresponding model numbers: 1. recall (Z-2891-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-08-05 |
| Philips Azurion under the following System Descriptions and corresponding model numbers: 1 recall (Z-2892-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-08-05 |
| Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluor recall (Z-2893-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-08-05 |
| Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiag recall (Z-2411-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-06-16 |
| Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C recall (Z-2412-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-06-16 |
| Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, recall (Z-2284-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-06-01 |
| Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, recall (Z-2285-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-06-01 |
| Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, recall (Z-2286-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-06-01 |
| Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, recall (Z-2287-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-06-01 |
| Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2. recall (Z-2288-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-06-01 |
| Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2. recall (Z-2289-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-06-01 |
| Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, recall (Z-2290-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-06-01 |
| Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, recall (Z-2291-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-06-01 |
| Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), A recall (Z-2258-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-05-28 |
| Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, recall (Z-2259-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-05-28 |
| Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the recall (Z-2225-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-05-21 |
| Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 recall (Z-2227-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-05-21 |
| Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura recall (Z-2228-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-05-21 |
| Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpa recall (Z-2229-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-05-21 |
| Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), A recall (Z-2170-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-05-12 |
| Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Int recall (Z-1805-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-04-10 |
| Allura Xper FD10C; System Code: 722001; recall (Z-1659-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| ALLURA Xper FD10F; System Code: 722002; recall (Z-1660-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; recall (Z-1661-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; recall (Z-1662-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; recall (Z-1663-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; recall (Z-1664-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; recall (Z-1665-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; recall (Z-1666-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; recall (Z-1667-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Allura Xper FD20/10; System Code: 722029; recall (Z-1668-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Allura Xper FD20/20; System Code: 722038; recall (Z-1669-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Allura Xper FD20/20 OR Table; System Code: 722039; recall (Z-1670-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Allura Xper FD20/15; System Code: 722058; recall (Z-1671-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Allura Xper FD20/15 OR Table; System Code: 722059; recall (Z-1672-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; recall (Z-1673-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); recall (Z-1674-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; recall (Z-1675-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; recall (Z-1676-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; recall (Z-1677-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); recall (Z-1678-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Azurion 5 M12; System Code: (1)722227, (2)722231; recall (Z-1679-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); recall (Z-1680-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Vue Motion V12. Product Number: 1017979. recall (Z-1692-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-03-27 |
| Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version N recall (Z-1344-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-02-11 |
| Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only recall (Z-1345-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-02-11 |
| Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Nu recall (Z-1346-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-02-11 |
| Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Numb recall (Z-1347-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-02-11 |
| Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Numb recall (Z-1348-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-02-11 |
| Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); recall (Z-1349-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-02-11 |
| Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All ve recall (Z-1350-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-02-11 |
| Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Ve recall (Z-1351-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-02-11 |
| Philips Azurion system; Software Version Number: R3.1; recall (Z-1113-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-16 |
| Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding recall (Z-1079-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-14 |
| Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following recall (Z-1091-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-14 |
| Product Name: Allura Xper FD10C; Model number: 722001; recall (Z-1062-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD10F; Model Number: 722002; recall (Z-1063-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD10; Model Number: 722003; recall (Z-1064-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD10/10; Model Number: 722005; recall (Z-1065-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD20; Model Number: 722006; recall (Z-1066-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD20 Biplane; Model Number: 722008; recall (Z-1067-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD10; Model Number: 722010; recall (Z-1068-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD10/10; Model Number: 722011; recall (Z-1069-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD20; Model Number: 722012; recall (Z-1070-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD20 Biplane; Model Number: 722013; recall (Z-1071-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD20 OR Table; Model Number: 722023; recall (Z-1072-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD10; Model Number: 722026; recall (Z-1073-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD10/10; Model Number: 722027; recall (Z-1074-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD20; Model Number: 722028; recall (Z-1075-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD20/10; Model Number: 722029; recall (Z-1076-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Allura Xper FD20/20; Model Number: 722038; recall (Z-1077-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2026-01-13 |
| Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234; recall (Z-0719-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-11-26 |
| Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system recall (Z-0241-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-23 |
| Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K1 recall (Z-0001-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K recall (Z-0002-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s recall (Z-0003-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K1 recall (Z-0004-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K recall (Z-0005-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K1020 recall (Z-0006-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k recall (Z-0007-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 5 recall (Z-0008-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, recall (Z-0009-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, recall (Z-0010-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, recall (Z-0011-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, recall (Z-0012-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, recall (Z-0013-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K1 recall (Z-0014-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K13063 recall (Z-0015-2026) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-10-01 |
| Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbe recall (Z-2623-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-25 |
| Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) nu recall (Z-2624-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-25 |
| Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: recall (Z-2625-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-25 |
| Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbe recall (Z-2626-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-25 |
| Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: recall (Z-2627-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-25 |
| Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510 recall (Z-2628-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-25 |
| Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) recall (Z-2629-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-25 |
| Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K1 recall (Z-2630-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-25 |
| Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K1 recall (Z-2631-2025) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 2025-09-25 |