Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT
- Recall date
- December 23, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1058-2017
- FDA classification
- Class II
- Brand / firm
- Philips Medical Systems (Cleveland) Inc
- Sold / distributed
- Product was not distributed in the US. Unit was distributed in Australia.
Why it was recalled
During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Brilliance iCT
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