BEUDAMED
    FDA Recall Terminated

    DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

    Recall: Z-2862-2018 · Initiated June 27, 2018

    Recall

    Recall Number
    Z-2862-2018
    Event Number
    80577
    Firm
    Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany
    FEI Number
    3003768251
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 27, 2018
    Posted
    August 17, 2018
    Terminated
    April 30, 2024

    Description

    DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

    Reason

    The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

    Action

    On June 27, 2018, Philips Medical Systems issued URGENT FIELD SAFETY NOTICES, Medical Device Recall letters to customers. Customers were encouraged to always check the right position of the hook and ensure that the hook is locked according tot he IFU. Press hook down until it is locked. Make sure that the hook is in position. A Philips Service Engineer will contact impacted customers as soon as the Field Action Kit is ready to be implemented. Should you need to communicate with Philips in regards to this program, please reference FCO-71200185. If you need further information or support concerning this issue, please contact your local Philips representative.

    Distribution

    US Nationwide; International to 66 countries