Countries where the notices were issued: Netherlands (73).
Name as written in the notices: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. This is the brand or the responsible company as each authority recorded it. A recall shows a safety system working; it is not a verdict on a brand. Follow the official notice for each product.
| Date | Authority | Product | Hazard (as classified) |
|---|
| 2026-07-16 | US FDA — Medical Devices | Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Versi | — |
| 2026-07-16 | US FDA — Medical Devices | Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, | — |
| 2026-04-30 | US FDA — Medical Devices | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), | — |
| 2026-04-30 | US FDA — Medical Devices | Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR T | — |
| 2026-04-28 | US FDA — Medical Devices | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 ( | — |
| 2026-04-28 | US FDA — Medical Devices | Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integ | — |
| 2026-04-28 | US FDA — Medical Devices | Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura X | — |
| 2026-03-19 | US FDA — Medical Devices | Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended | — |
| 2025-12-15 | US FDA — Medical Devices | Allura Xper FD10F; Model Number: 722002; | — |
| 2025-12-15 | US FDA — Medical Devices | Allura Xper FD10/10; Model Number: 722027; | — |
| 2025-12-15 | US FDA — Medical Devices | Allura Xper FD20; Model Number: 722028; | — |
| 2025-12-15 | US FDA — Medical Devices | Product Name: Allura Xper FD10C; Model number: 722001; | — |
| 2025-12-15 | US FDA — Medical Devices | Allura Xper FD10; Model Number: 722003; | — |
| 2025-12-15 | US FDA — Medical Devices | Allura Xper FD10/10; Model Number: 722011; | — |
| 2025-12-15 | US FDA — Medical Devices | Allura Xper FD20/20; Model Number: 722038; | — |
| 2025-12-15 | US FDA — Medical Devices | Allura Xper FD10/10; Model Number: 722005; | — |
| 2025-12-15 | US FDA — Medical Devices | Allura Xper FD20; Model Number: 722012; | — |
| 2025-12-15 | US FDA — Medical Devices | Allura Xper FD20/10; Model Number: 722029; | — |
| 2025-12-12 | US FDA — Medical Devices | Philips Azurion system; Software Version Number: R3.1; | — |
| 2025-12-12 | US FDA — Medical Devices | Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corres | — |
| 2025-12-08 | US FDA — Medical Devices | Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. M | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K13 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K1306 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K1 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K1 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K16 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K13084 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K13329 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419 | — |
| 2025-09-03 | US FDA — Medical Devices | Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K1 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K13 | — |
| 2025-09-03 | US FDA — Medical Devices | Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K1 | — |
| 2025-03-24 | US FDA — Medical Devices | Intera 1.5T Master/Nova, Model Number: 781106; | — |
| 2025-03-24 | US FDA — Medical Devices | SmartPath to dStream for 3.0T, Model Number: 782145; | — |
| 2025-03-24 | US FDA — Medical Devices | Intera 1.5T Explorer/Nova Dual, Model Number: 781108; | — |
| 2025-03-24 | US FDA — Medical Devices | SmartPath to dStream for 1.5T, Model Number: 782146; | — |
| 2025-03-24 | US FDA — Medical Devices | Intera 1.0T Omni/Stellar, Model Number: 781102; | — |
| 2025-03-24 | US FDA — Medical Devices | Enterprise 1.5T, Model Number: 781145; | — |
| 2025-03-24 | US FDA — Medical Devices | Intera 1.5T Omni/Stellar, Model Number: 781104; | — |
| 2025-03-24 | US FDA — Medical Devices | Intera 0.5T Standard, Model Number: 781101; | — |
| 2025-03-24 | US FDA — Medical Devices | Intera 3.0T Quasar Dual, Model Number: 781150; | — |
| 2025-03-24 | US FDA — Medical Devices | Intera 1.5T Power/Pulsar, Model Number: 781105; | — |
| 2025-01-13 | US FDA — Medical Devices | Azurion 3 M12 System Code: (1) 722063 (2) 722221 | — |
| 2025-01-13 | US FDA — Medical Devices | Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235 | — |
| 2025-01-13 | US FDA — Medical Devices | Allura CV20 System Code: 722031 | — |
| 2025-01-13 | US FDA — Medical Devices | Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236 | — |
| 2025-01-13 | US FDA — Medical Devices | AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028 | — |
| 2025-01-13 | US FDA — Medical Devices | AlluraXperFD20/10 System Code: (1) 722029 | — |
| 2025-01-13 | US FDA — Medical Devices | AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013 | — |
| 2025-01-13 | US FDA — Medical Devices | Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 | — |
| 2025-01-13 | US FDA — Medical Devices | AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035 | — |
| 2025-01-13 | US FDA — Medical Devices | AlluraXperFD20/15 System Code: (1) 722058 | — |
| 2025-01-13 | US FDA — Medical Devices | Azurion 5 M12 System Code: (1) 722227 (2) 722231 | — |
| 2025-01-13 | US FDA — Medical Devices | AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027 | — |
| 2024-11-11 | US FDA — Medical Devices | Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. | — |
| 2024-08-06 | US FDA — Medical Devices | Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Number | — |
| 2024-02-06 | US FDA — Medical Devices | Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg | — |
| 2024-02-06 | US FDA — Medical Devices | Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive sur | — |
| 2024-01-02 | US FDA — Medical Devices | Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected | — |
| 2024-01-02 | US FDA — Medical Devices | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected | — |