FDAApril 6, 2020device

Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848

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

The hazard

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

UPCs

00884838059474

Recall history

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

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