FDAJanuary 18, 2017device

Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

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

The hazard

During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.

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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