FDA DeviceClass IINotable

FDA Recall: ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

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

2291 units (493 US, 1798 OUS)

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