FDA recall Z-0331-2018

Product

Philips Healthcare Brilliance iCT computed tomography x-ray system

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-11-08

Report date

2018-01-17

Termination date

2020-04-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cleveland, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0331-2018