BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2805-2015 · Initiated June 30, 2015

    Recall

    Recall Number
    Z-2805-2015
    Event Number
    71706
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    2431293
    Product Code
    FET
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 30, 2015
    Posted
    September 22, 2015
    Terminated
    May 25, 2017
    Address
    10 Highpoint Dr, Wayne, NJ, 07470-7431

    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.

    Action

    Fujifilm Medical Systems USA, Inc. initiated this recall by sending a Voluntary Field Correction Letter and Tracking/Verification Form dated June 30, 2013 to their affected customers.

    Distribution

    Nationwide US and Canada

    Quantity

    60