BEUDAMED
    FDA Enforcement Class II Terminated

    Uretero-reno fiberscope URF-P6RP6

    Recall: Z-2520-2018 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2520-2018
    Event ID
    79701
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2018
    Initiation Date
    January 17, 2018
    Classification Date
    July 20, 2018
    Termination Date
    December 4, 2019
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    Uretero-reno fiberscope URF-P6RP6

    Reason

    Breakage of the endoscope's insertion tube bending section during surgical procedures.

    Code Info

    All serial numbers

    Distribution

    US Nationwide. Canada and Mexico

    Quantity

    2399