FDANovember 12, 2021device

BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075

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

The hazard

Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

00884838055490

Recall history

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

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