BEUDAMED
    FDA Recall Terminated

    Brilliance iCT

    Recall: Z-1058-2017 · Initiated December 23, 2016

    Recall

    Recall Number
    Z-1058-2017
    Event Number
    76144
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 23, 2016
    Terminated
    June 26, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance iCT

    Reason

    During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.

    Action

    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.

    Distribution

    Product was not distributed in the US. Unit was distributed in Australia.

    Quantity

    1-unit