Philips Medical Systems (Cleveland) Inc recalls Philips Healthcare Brilliance iCT computed tomography x-ray system

Recall date

November 8, 2017

Source

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

Recall number

Z-0331-2018

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts

Why it was recalled

There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.

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 iCT computed tomography x-ray system