BEUDAMED
    FDA Enforcement Class II Terminated

    Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs

    Recall: Z-2706-2017 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2706-2017
    Event ID
    76899
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2017
    Initiation Date
    February 17, 2017
    Classification Date
    July 10, 2017
    Termination Date
    October 3, 2018
    Address
    10 Highpoint Dr, Wayne, NJ, 07470-7431, United States

    Description

    Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs

    Reason

    Fujifilm is recalling multiple endoscopes after a retrospective review.

    Code Info

    1U881A131 1U88A1A145 3U881A005

    Distribution

    US Distribution to : AL, HI and MO

    Quantity

    4 units