BEUDAMED
    FDA Recall Terminated

    Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories

    Recall: Z-1004-2017 · Initiated November 25, 2016

    Recall

    Recall Number
    Z-1004-2017
    Event Number
    76021
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 25, 2016
    Terminated
    July 2, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories

    Reason

    Failure to correctly document the installation of four M12 Bolts into the system rotor.

    Action

    Philips sent a Customer Information Letter to their customer. The letter identified the affected product, problem description and actions to be taken by customers. For further information or support concerning this issue, contact your local Philips representative or local Philips Healthcare office. For SUPPORT North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377).

    Distribution

    The one system was distributed in Canada. There were no government or US distribution.

    Quantity

    1