BEUDAMED
    FDA Recall Terminated

    Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection

    Recall: Z-1861-2016 · Initiated December 23, 2015

    Recall

    Recall Number
    Z-1861-2016
    Event Number
    73469
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    2431293
    Product Code
    FDT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 23, 2015
    Terminated
    January 18, 2018
    Address
    10 Highpoint Dr, Wayne, NJ, 07470-7431

    Description

    Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection

    Reason

    This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.

    Action

    Fujifilm issued a urgent field correction/Tracking/Verification form on 12/23/2015.

    Distribution

    Nationwide Distribution.

    Quantity

    98 units