BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance iCT

    Recall: Z-1058-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1058-2017
    Event ID
    76144
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2017
    Initiation Date
    December 23, 2016
    Classification Date
    January 20, 2017
    Termination Date
    June 26, 2018
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    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.

    Code Info

    Rotor-4535-673-94382 SN 19, installed on Brilliance ICT System S/N 200203

    Distribution

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

    Quantity

    1-unit