BEUDAMED
    FDA Recall Terminated

    Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes.

    Recall: Z-0708-06 · Initiated March 27, 2006

    Recall

    Recall Number
    Z-0708-06
    Event Number
    34680
    Firm
    Fujinon Inc
    FEI Number
    2431293
    Product Code
    FDF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 27, 2006
    Posted
    April 5, 2006
    Terminated
    December 3, 2007
    Address
    10 Highpoint Dr, Wayne, NJ, 07470-7431

    Description

    Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes.

    Reason

    Colonoscope insertion tube is not bending properly and is stiff.

    Action

    Fujinon sent out a Technical Bulletin on 3/27/2006 that instructs the physician to do a bending test with the colonoscope. If the scope does not bend around an 8 inch bending diameter, the scope is not to be used.

    Distribution

    Product is distributed nationwide to hospitals and physicians. It was shipped internationally to Canada. US Government accounts include VA medical centers in Spokane WA, St. Louis, MO and Camp Pendleton Naval Hospital in Camp Pendleton, CA.

    Quantity

    2335 UNITS