BEUDAMED
    FDA Enforcement Class II Terminated

    Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection

    Recall: Z-1861-2016 · Reported June 8, 2016

    Enforcement

    Recall Number
    Z-1861-2016
    Event ID
    73469
    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
    June 8, 2016
    Initiation Date
    December 23, 2015
    Classification Date
    May 31, 2016
    Termination Date
    January 18, 2018
    Address
    10 Highpoint Dr, N/A, Wayne, NJ, 07470-7431, United States

    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.

    Code Info

    All distribution dates :3/2003-4/2016

    Distribution

    Nationwide Distribution.

    Quantity

    98 units