Brand

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.
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K1628...
Medical Devices·501 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·115 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162...
Medical Devices·3 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·313 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Medical Devices·8 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K...
Medical Devices·298 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1...
Medical Devices·5 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K...
Medical Devices·5,067 affected·Sep 3, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
IntelliSpace Cardiovascular, Software 8.0.0.4.
Medical Devices·4 affected·Aug 8, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numb...
Medical Devices·1,861 affected·Aug 1, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model N...
Medical Devices·4,508 affected·Jun 30, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20. Fluoroscopic X-Ray System.
Medical Devices·78 affected·Jun 4, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Medical Devices·996 affected·Apr 7, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Master/Nova, Model Number: 781106;
Medical Devices·103 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
SmartPath to dStream for 3.0T, Model Number: 782145;
Medical Devices·4 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
Medical Devices·12 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
SmartPath to dStream for 1.5T, Model Number: 782146;
Medical Devices·3 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.0T Omni/Stellar, Model Number: 781102;
Medical Devices·37 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Enterprise 1.5T, Model Number: 781145;
Medical Devices·34 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Omni/Stellar, Model Number: 781104;
Medical Devices·26 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 0.5T Standard, Model Number: 781101;
Medical Devices·14 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 3.0T Quasar Dual, Model Number: 781150;
Medical Devices·12 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Power/Pulsar, Model Number: 781105;
Medical Devices·121 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Medical Devices·1 affected·Feb 28, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M12 System Code: (1) 722063 (2) 722221
Medical Devices·9 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
Medical Devices·479 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
Medical Devices·735 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura CV20; Catalog numbers: 722031
Medical Devices·111 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
Medical Devices·4,221 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
Medical Devices·263 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
Medical Devices·90 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura CV20 System Code: 722031
Medical Devices·119 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
Medical Devices·251 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
Medical Devices·1,528 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Medical Devices·5,029 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
Medical Devices·3 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXperFD20/10 System Code: (1) 722029
Medical Devices·22 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
Medical Devices·66 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/15; Catalog numbers: 722058
Medical Devices·302 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
Medical Devices·1,346 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
Medical Devices·282 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
Medical Devices·1 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXperFD20/15 System Code: (1) 722058
Medical Devices·69 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 5 M12 System Code: (1) 722227 (2) 722231
Medical Devices·6 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
Medical Devices·146 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
Medical Devices·2 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/...
Medical Devices·2,782 affected·Nov 11, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion...
Medical Devices·7,091 affected·Aug 22, 2024