FDAOctober 18, 2018device

Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient ...

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

The hazard

There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall

What to do

FDA enforcement status: Terminated

Brands named

philips medical systems clevelandphilipsphilips medical

Recall history

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

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