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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.
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722...
Medical Devices·250 affected·Aug 22, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
Medical Devices·6 affected·Aug 8, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
Medical Devices·927 affected·Aug 6, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in ...
Diagnostic Devices·3,011 affected·Jul 15, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
Medical Devices·3 affected·May 16, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
Medical Devices·1 affected·May 16, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascu...
Cardiac Devices·391 affected·May 2, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures ...
Diagnostic Devices·10 affected·Feb 6, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures ...
Diagnostic Devices·14 affected·Feb 6, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affec...
Medical Devices·1,993 affected·Jan 2, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affe...
Medical Devices·1,993 affected·Jan 2, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affec...
Medical Devices·13 affected·Jan 2, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affe...
Medical Devices·13 affected·Jan 2, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Az...
Medical Devices·1,799 affected·Dec 12, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Medical Devices·28 affected·Dec 8, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Diagnostic Devices·19,115 affected·Aug 15, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-steril...
Medical Devices·12 affected·Jul 20, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper series
Medical Devices·5,432 affected·Jul 19, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion
Medical Devices·5,432 affected·Jul 19, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Medical Devices·1,865 affected·Jun 30, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20. X-ray Image guided Therapy System.
Medical Devices·648 affected·Jun 12, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10 and FD20. X-ray Imaging System.
Medical Devices·648 affected·Jun 12, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 7220...
Medical Devices·1,063 affected·Mar 21, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Medical Devices·1,461 affected·Feb 20, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Zenition 50, Model #718096
Medical Devices·16 affected·Dec 2, 2021
High RiskFDA
Philips Medical Systems Nederland B.v.
Veradius Unity, Model #718132
Medical Devices·12 affected·Dec 2, 2021