FDA DeviceClass IINotable

FDA Recall: Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

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

298 units (27 US, 271 OUS)

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