BEUDAMED
    FDA Recall Terminated

    Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.

    Recall: Z-1461-2014 · Initiated March 27, 2014

    Recall

    Recall Number
    Z-1461-2014
    Event Number
    67837
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 27, 2014
    Posted
    April 16, 2014
    Terminated
    February 2, 2016
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.

    Reason

    Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table tops subframe.

    Action

    A Field Safety Notice was sent to all US consignees via certified mail. Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.

    Distribution

    Nationwide Distribution - USA including the states of CA, FL, IL, IN, KY, MD,SC, and TX.

    Quantity

    135