BEUDAMED
    FDA Enforcement Class II Terminated

    Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.

    Recall: Z-0112-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0112-2014
    Event ID
    66144
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fujinon Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2013
    Initiation Date
    July 31, 2013
    Classification Date
    October 29, 2013
    Termination Date
    March 4, 2014
    Address
    10 Highpoint Dr, N/A, Wayne, NJ, 07470, United States

    Description

    Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.

    Reason

    A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.

    Code Info

    Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029

    Distribution

    Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.

    Quantity

    12 Units