BEUDAMED
    FDA Recall Terminated

    Brilliance 64, Model 728231 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-0543-2019 · Initiated October 18, 2018

    Recall

    Recall Number
    Z-0543-2019
    Event Number
    81569
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 18, 2018
    Terminated
    August 3, 2021
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance 64, Model 728231 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

    There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall

    Action

    On October 18, 2018, Philips notices to their customers via courier service. Customers were advised to take the following actions: If any unusual noise is heard, discontinue use of the system immediately and contact your Philips representative for support. Field Order Change (FCO) 72800703 will be deployed to initiate an inspection of the front gantry cover. If the inspection finds evidence of weakening at this connection point, a temporary repair solution will be put in place to secure the cover for continued system use. FCO 72800704 will then be deployed to replace the affected front cover. A Philips Field Service Engineer will contact you to schedule the inspection of your system. Customers in need of further information or support concerning this issue, please contact your local Philips representative (North America & Canada) 1-800-722-9377.

    Distribution

    US Nationwide Distribution

    Quantity

    6,343 units in total