BEUDAMED
    FDA Recall Terminated

    Fujinon Endoscope Series; Model # EPX-4400 and EPX-4400HD. Digital processing of images from endoscope.

    Recall: Z-1067-2011 · Initiated January 7, 2011

    Recall

    Recall Number
    Z-1067-2011
    Event Number
    57676
    Firm
    Fujinon Inc
    FEI Number
    2431293
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    January 7, 2011
    Posted
    February 9, 2011
    Terminated
    June 4, 2012
    Address
    10 Highpoint Dr, Wayne, NJ, 07470

    Description

    Fujinon Endoscope Series; Model # EPX-4400 and EPX-4400HD. Digital processing of images from endoscope.

    Reason

    The FICE feature installed in video endoscopic processors is being disabled since this feature should have been reviewed under the premarket notification/510k process.

    Action

    Fujinon sent an Urgent Medical Device Corrective Action Letter, dated 1/7/2011, via overnight mail to all consignees. The letter advises users that the FICE feature should no longer be used and that a Fujinon Field Service Engineer will be coming to physically disable the FICE feature on the processor. Instructions labeled as Attachment B are provided to assist in ceasing use of the FICE function. Attachment A is provided for frequently asked questions. Customers are to complete the Response/Acknowledgement Form and either fax it or email back to the firm. If there are additional questions, customers can call 800-385-4666 or email [email protected].

    Distribution

    Nationwide Distribution

    Quantity

    783 units