BEUDAMED
    FDA Enforcement Class II Terminated

    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.

    Recall: Z-2805-2015 · Reported September 30, 2015

    Enforcement

    Recall Number
    Z-2805-2015
    Event ID
    71706
    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
    September 30, 2015
    Initiation Date
    June 30, 2015
    Classification Date
    September 22, 2015
    Termination Date
    May 25, 2017
    Address
    10 Highpoint Dr, N/A, Wayne, NJ, 07470-7431, United States

    Description

    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.

    Reason

    The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with the 2500 processor, a "super image" is displayed when it is actually a "standard image" that is displayed.

    Code Info

    Part Numbers: 202B1230408A, 202B1230408B, 202B1230408C, 202B1230408D and 202B1230408E

    Distribution

    Nationwide US and Canada

    Quantity

    60