FDA-Device2018-01-17Class II
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Philips Medical Systems (Cleveland) Inc
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.
Sold states
107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
Affected count
134
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0332-2018Don't want to check this manually?
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