FDAJanuary 2, 2024device

Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 72...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.

What to do

FDA enforcement status: Ongoing

Brands named

philips medical systems nederland b vphilipsphilips medical

UPCs

008848380590300088483805418900884838054196008848380591150088483805905400884838059191008848380592070088483805420200884838059269008848380590610088483808080500884838059085

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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