FDA DeviceClass IINotable
FDA Recall: Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
Description
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Hazard
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Remedy
670 units (106 US, 564 OUS)
Related Recalls
2026-04-22 · FDA_DEVICE
FDA Recall: Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Intervent
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2026-04-08 · FDA_DEVICE
FDA Recall: Allura Xper FD20/10; System Code: 722029;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2026-04-08 · FDA_DEVICE
FDA Recall: ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2026-04-08 · FDA_DEVICE
FDA Recall: Allura Xper FD20/20; System Code: 722038;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.