BEUDAMED
    FDA Enforcement Class II 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 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2778-2015
    Event ID
    71695
    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 23, 2015
    Initiation Date
    June 30, 2015
    Classification Date
    September 17, 2015
    Termination Date
    May 25, 2017
    Address
    10 Highpoint Dr, Wayne, NJ, 07470-7431, United States

    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.

    Code Info

    ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681

    Distribution

    Distributed in the US and Canada.

    Quantity

    256 units