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Philips Medical Systems Nederland B.v. Recalls

122 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Philips Medical Systems Nederland B.v..

122Total Recalls
10Critical
117,939Units Affected
Mar 19, 2026Most Recent
All Recalls

Every Philips Medical Systems Nederland B.v. Recall

Sorted by most recent. Click any recall for full details.

122 recalls
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in co...
Medical Devices·1,033 affected·Mar 19, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Medical Devices·461 affected·Mar 3, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15 OR Table; System Code: 722059;
Medical Devices·2 affected·Mar 3, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Medical Devices·298 affected·Mar 3, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Medical Devices·1,523 affected·Mar 3, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 5 M12; System Code: (1)722227, (2)722231;
Medical Devices·345 affected·Mar 3, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
Medical Devices·4 affected·Mar 3, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
ALLURA Xper FD10F; System Code: 722002;
Medical Devices·10 affected·Mar 3, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/10; System Code: 722029;
Medical Devices·85 affected·Mar 3, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Medical Devices·196 affected·Mar 3, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
Medical Devices·798 affected·Mar 3, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Medical Devices·1,994 affected·Mar 3, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical Devices·1,979 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X,...
Medical Devices·5,136 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical Devices·655 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical Devices·326 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1...
Medical Devices·802 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical Devices·291 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10F; Model Number: 722002;
Medical Devices·12 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10/10; Model Number: 722027;
Medical Devices·22 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20; Model Number: 722028;
Medical Devices·2 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Product Name: Allura Xper FD10C; Model number: 722001;
Medical Devices·38 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10; Model Number: 722003;
Medical Devices·93 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10/10; Model Number: 722011;
Medical Devices·21 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/20; Model Number: 722038;
Medical Devices·8 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10/10; Model Number: 722005;
Medical Devices·14 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20; Model Number: 722012;
Medical Devices·79 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/10; Model Number: 722029;
Medical Devices·4 affected·Dec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion system; Software Version Number: R3.1;
Medical Devices·228 affected·Dec 12, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: ...
Medical Devices·10,466 affected·Dec 12, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 7222...
Medical Devices·990 affected·Dec 8, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Medical Devices·29 affected·Sep 29, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1...
Medical Devices·268 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033...
Medical Devices·98 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141...
Medical Devices·286 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162...
Medical Devices·1 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K...
Medical Devices·2 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K...
Medical Devices·2,317 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·300 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·87 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·5 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·2 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K04...
Medical Devices·46 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·2 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979...
Medical Devices·1,117 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K1419...
Medical Devices·4 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·53 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292...
Medical Devices·174 affected·Sep 3, 2025