BEUDAMED
    FDA Recall Terminated

    Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.

    Recall: Z-3128-2017 · Initiated March 9, 2015

    Recall

    Recall Number
    Z-3128-2017
    Event Number
    76905
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    2431293
    Product Code
    FDT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 9, 2015
    Terminated
    July 2, 2018
    Address
    10 Highpoint Dr, Wayne, NJ, 07470-7431

    Description

    Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.

    Reason

    Fujifilm is reporting a corrective action due to an FDA inspection.

    Action

    Fujifilm notified their customers on 3/9/2015. Customers are advised of the updated manuals. and asked to destroyed existing manuals. Questions, comments and concerns should be directed to 800.385.4666 between the areas of 8:00 am and 5:00 pm EST or via email at [email protected].

    Distribution

    US Nationwide Distribution

    Quantity

    260 manuals in total