Reported Feb 1, 2017 · Terminated
Brilliance iCT
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Brilliance iCT
- Lot codes and dates
- Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203
- Amount recalled
- 1-unit
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.
This product could cause temporary or reversible health problems — stop using it.
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