FDANovember 3, 2015device

Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysi...

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

The hazard

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

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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