BEUDAMED
    FDA Enforcement Class II Terminated

    Airway Mobilescope MAF-TM

    Recall: Z-3311-2018 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-3311-2018
    Event ID
    80925
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2018
    Initiation Date
    August 8, 2018
    Classification Date
    September 29, 2018
    Termination Date
    May 17, 2022
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    Airway Mobilescope MAF-TM

    Reason

    The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

    Code Info

    all lot codes

    Distribution

    The products were distributed US nationwide and Canada.

    Quantity

    3456