BEUDAMED
    FDA Recall Terminated

    Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.

    Recall: Z-2778-2015 · Initiated June 30, 2015

    Recall

    Recall Number
    Z-2778-2015
    Event Number
    71695
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    2431293
    Product Code
    FDT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 30, 2015
    Posted
    September 17, 2015
    Terminated
    May 25, 2017
    Address
    10 Highpoint Dr, Wayne, NJ, 07470-7431

    Description

    Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.

    Reason

    The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.

    Action

    FujiFilm sent a Voluntary Field Correction/Verification Form dated June 30, 2015 to their affected customers.

    Distribution

    Distributed in the US and Canada.

    Quantity

    256 units