PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
112 recalls on record · Latest: Jan 28, 2026
FDA Devices Moderate Jan 28, 2026
Philips Azurion system; Software Version Number: R3.1;
FDA Devices Moderate Jan 21, 2026
Allura Xper FD10F; Model Number: 722002;
FDA Devices Moderate Jan 21, 2026
Allura Xper FD10/10; Model Number: 722027;
FDA Devices Moderate Jan 21, 2026
Allura Xper FD20; Model Number: 722028;
FDA Devices Moderate Jan 21, 2026
Product Name: Allura Xper FD10C; Model number: 722001;
FDA Devices Moderate Jan 21, 2026
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. A…
FDA Devices Moderate Jan 21, 2026
Allura Xper FD10; Model Number: 722003;
FDA Devices Moderate Jan 21, 2026
Allura Xper FD10/10; Model Number: 722011;
FDA Devices Moderate Jan 21, 2026
Allura Xper FD20/20; Model Number: 722038;
FDA Devices Moderate Jan 21, 2026
Allura Xper FD10/10; Model Number: 722005;
FDA Devices Moderate Jan 21, 2026
Allura Xper FD20; Model Number: 722012;
FDA Devices Moderate Jan 21, 2026
Allura Xper FD20/10; Model Number: 722029;
FDA Devices Moderate Jan 21, 2026
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion…
FDA Devices Moderate Oct 29, 2025
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
FDA Devices Moderate Oct 8, 2025
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161…
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Devices Moderate Oct 8, 2025
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Devices Moderate Oct 8, 2025
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,…
FDA Devices Moderate Oct 8, 2025
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Devices Moderate Oct 8, 2025
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162…
FDA Devices Moderate Oct 8, 2025
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161…
FDA Devices Moderate Oct 8, 2025
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K…
FDA Devices Moderate Oct 1, 2025
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K1628…
FDA Devices Moderate Oct 1, 2025
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Devices Moderate Oct 1, 2025
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563…
FDA Devices Moderate Oct 1, 2025
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737…
FDA Devices Moderate Oct 1, 2025
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162…
FDA Devices Moderate Oct 1, 2025
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Devices Moderate Oct 1, 2025
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K…
FDA Devices Moderate Oct 1, 2025
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K…
FDA Devices Moderate Oct 1, 2025
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737…
FDA Devices Moderate Oct 1, 2025
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615…
FDA Devices Moderate Sep 17, 2025
IntelliSpace Cardiovascular, Software 8.0.0.4.
FDA Devices Moderate Sep 10, 2025
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. …
FDA Devices Moderate Sep 10, 2025
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1…
FDA Devices Moderate Aug 6, 2025
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 72202…
FDA Devices Moderate Jul 30, 2025
Azurion 7 M20. Fluoroscopic X-Ray System.
FDA Devices Moderate May 21, 2025
Intera 1.5T Master/Nova, Model Number: 781106;
FDA Devices Moderate May 21, 2025
SmartPath to dStream for 3.0T, Model Number: 782145;
FDA Devices Moderate May 21, 2025
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
FDA Devices Moderate May 21, 2025
SmartPath to dStream for 1.5T, Model Number: 782146;
FDA Devices Moderate May 21, 2025
Intera 1.0T Omni/Stellar, Model Number: 781102;
FDA Devices Moderate May 21, 2025