Philips Medical Systems (Cleveland) Inc recalls Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by compu…

Recall date

March 16, 2015

Source

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

Recall number

Z-1654-2015

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Distributed in China.

Why it was recalled

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

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 CT 10 Air. 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.