FDA DeviceClass IINotable

FDA Recall: Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

Date: 2026-04-08
Brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device
FDA Class: Class II

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

5167 units (1728 US, 3439 OUS)

View original recall →
Share:

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.