FDAApril 13, 2021device

BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

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

The hazard

Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

Recall history

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

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