Philips Electronics North America Corporation recalls Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intend…

Recall date

January 18, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0015-2018

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

USA (nationwide) Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.