BEUDAMED
    FDA Enforcement Class II Terminated

    Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603

    Recall: Z-1929-2017 · Reported May 10, 2017

    Enforcement

    Recall Number
    Z-1929-2017
    Event ID
    76488
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 10, 2017
    Initiation Date
    February 10, 2017
    Classification Date
    May 3, 2017
    Termination Date
    May 9, 2018
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603

    Reason

    A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.

    Code Info

    All serial numbers

    Distribution

    Nationwide

    Quantity

    863 units