FDANovember 19, 2021device

Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 72...

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

The hazard

Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention.

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

UPCs

008848380542020088483805905400884838059030008848380591910088483805418900884838054196

Recall history

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

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