FDA DeviceClass IINotable

FDA Recall: Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (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

798 units (42 US, 756 OUS)

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