PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
112 recalls on record · Latest: Jan 28, 2026
FDA Devices Moderate May 21, 2025
Intera 1.5T Omni/Stellar, Model Number: 781104;
FDA Devices Moderate May 21, 2025
Intera 0.5T Standard, Model Number: 781101;
FDA Devices Moderate May 21, 2025
Intera 3.0T Quasar Dual, Model Number: 781150;
FDA Devices Moderate May 21, 2025
Intera 1.5T Power/Pulsar, Model Number: 781105;
FDA Devices Moderate May 21, 2025
Intera 1.5T R11, Model Number: 781170;
FDA Devices Moderate May 14, 2025
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
FDA Devices Moderate Apr 30, 2025
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environmen…
FDA Devices Moderate Mar 19, 2025
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
FDA Devices Critical Feb 26, 2025
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
FDA Devices Critical Feb 26, 2025
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
FDA Devices Critical Feb 26, 2025
Allura CV20; Catalog numbers: 722031
FDA Devices Critical Feb 26, 2025
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Devices Critical Feb 26, 2025
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
FDA Devices Critical Feb 26, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Devices Critical Feb 26, 2025
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
FDA Devices Critical Feb 26, 2025
Allura Xper FD20/15; Catalog numbers: 722058
FDA Devices Critical Feb 26, 2025
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
FDA Devices Critical Feb 26, 2025
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
FDA Devices Critical Feb 26, 2025
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Devices Moderate Feb 12, 2025
Azurion 3 M12 System Code: (1) 722063 (2) 722221
FDA Devices Moderate Feb 12, 2025
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
FDA Devices Moderate Feb 12, 2025
Allura CV20 System Code: 722031
FDA Devices Moderate Feb 12, 2025
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
FDA Devices Moderate Feb 12, 2025
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
FDA Devices Moderate Feb 12, 2025
AlluraXperFD20/10 System Code: (1) 722029
FDA Devices Moderate Feb 12, 2025
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
FDA Devices Moderate Feb 12, 2025
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
FDA Devices Moderate Feb 12, 2025
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
FDA Devices Moderate Feb 12, 2025
AlluraXperFD20/15 System Code: (1) 722058
FDA Devices Moderate Feb 12, 2025
Azurion 5 M12 System Code: (1) 722227 (2) 722231
FDA Devices Moderate Feb 12, 2025
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
FDA Devices Moderate Feb 12, 2025
Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
FDA Devices Moderate Feb 12, 2025
Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
FDA Devices Moderate Dec 18, 2024
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Nu…
FDA Devices Moderate Sep 25, 2024
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 7 M12 72222…
FDA Devices Moderate Sep 25, 2024
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris…
FDA Devices Moderate Sep 25, 2024
System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 All…
FDA Devices Moderate Sep 25, 2024
System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagn…
FDA Devices Moderate Sep 11, 2024
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
FDA Devices Moderate Aug 28, 2024
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
FDA Devices Moderate Aug 14, 2024
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, …
FDA Devices Moderate Jun 5, 2024
Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
FDA Devices Moderate Jun 5, 2024
Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
FDA Devices Moderate Jun 5, 2024
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
FDA Devices Moderate Feb 28, 2024
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: Fle…
FDA Devices Moderate Feb 28, 2024
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Fl…
FDA Devices Moderate Feb 28, 2024
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1…
FDA Devices Moderate Feb 28, 2024
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRa…
FDA Devices Moderate Feb 28, 2024
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (…
FDA Devices Moderate Feb 28, 2024