Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body…

Recall date

November 25, 2016

Source

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

Recall number

Z-1004-2017

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

The one system was distributed in Canada. There were no government or US distribution.

Why it was recalled

Failure to correctly document the installation of four M12 Bolts into the system rotor.

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

What was recalled

Brilliance iCT 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 and equipment supports, components, and accessories