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Philips Medical Systems (Cleveland) Inc recalls Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Recalled January 17, 2018 · FDA recall Z-0332-2018 · Philips Medical Systems (Cleveland)
Hazard
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. · FDA Class II
Units
134
Sold at
107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
Description
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.
Product
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →