BEUDAMED
    FDA Recall Terminated

    Colonovideoscope Model CF-H180AL

    Recall: Z-1274-2022 · Initiated April 22, 2022

    Recall

    Recall Number
    Z-1274-2022
    Event Number
    90218
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FDF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 22, 2022
    Terminated
    March 13, 2024
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Colonovideoscope Model CF-H180AL

    Reason

    A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding

    Action

    Olympus issued letter via e-mail on April 22, 2022. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. 2. An Olympus representative will contact you to arrange for the return of your affected device. Olympus will repair your unit free of charge. 3. Olympus will provide a service loaner device in an effort to not disrupt patient care. Contact: 647-999-3203 or at [email protected]

    Distribution

    US Nationwide distribution in the state of KY.

    Quantity

    1 unit