FDA DeviceClass IINotable

FDA Recall: Allura Xper FD20/15; System Code: 722058;

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

296 units (68 US, 228 OUS)

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