Brilliance iCT
This recall has been terminated (originally issued December 23, 2016).
- Recall Initiated
- December 23, 2016
- Terminated
- June 26, 2018
- Recall Number
- Z-1058-2017
- Quantity
- 1-unit
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
Reason for Recall
During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
Distribution
Product was not distributed in the US. Unit was distributed in Australia.
Lot / Code Info
Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203
Root Cause
Employee error
Action Taken
Philips sent an Customer Information letter. A document showed an incorrect torque wrench used during the assembly process which could potentially apply 4 Newton-meters less torque than specified to the system rotor counterweight bolts. Out of an abundance of caution, Philips will have a Field Service Engineer ensure the bolts on your system are correctly torqued. If you need any further information or support concerning this issue, please contact your local Philips representative. For further information please call (440) 483-5777.