FDA-Device2017-02-01Class II
Brilliance iCT
Philips Medical Systems (Cleveland) Inc
Hazard
During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
Sold states
Product was not distributed in the US. Unit was distributed in Australia.
Affected count
1-unit
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Brilliance iCT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1058-2017Don't want to check this manually?
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