FDAMarch 14, 2018device

Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diag...

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

The hazard

After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself.

What to do

FDA enforcement status: Terminated

Brands named

philips electronics north americaphilipsphilips electronics

Recall history

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

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