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High risk Medical DevicesClass II

Philips ALLURA Xper FD20 Biplane Recall

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

Updated March 3, 2026

The Philips ALLURA Xper FD20 Biplane X-ray system may fail to initiate imaging or produce only intermittent X-ray exposure when using the wired foot switch, potentially compromising diagnostic accuracy and patient care during medical procedures.

Is the PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled? Yes. This product was recalled by FDA on March 3, 2026. Details below.

What is recalled

Philips ALLURA Xper FD20 Biplane X-ray imaging systems with System Code 722008 or 722013.

Am I affected

You're affected if your medical facility operates a Philips ALLURA Xper FD20 Biplane system and the system code on your device is either 722008 or 722013.

What to do right now

Contact Philips Medical Systems Nederland B.V. directly for instructions on how to address this issue with the wired foot switch. Do not rely on the foot switch until you receive guidance from the manufacturer.

The hazard

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Brands affected

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1664-2026
Classification
Class II
Recalled
March 3, 2026
Read the official notice

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