BEUDAMED
    FDA Recall Terminated

    Fuse 1C Colonoscope

    Recall: Z-0694-2016 · Initiated December 18, 2015

    Recall

    Recall Number
    Z-0694-2016
    Event Number
    73067
    Firm
    EndoChoice, Inc. 11810 Wills Rd Ste 100 ATTN: Theron Gober Alpharetta GA 30009-2081
    FEI Number
    3032507796
    Product Code
    FDF
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 18, 2015
    Posted
    January 27, 2016
    Terminated
    March 24, 2016

    Description

    Fuse 1C Colonoscope

    Reason

    The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.

    Action

    Consignees were notified on12/09/2015 that a sales representative would be contacting them to facilitate the exchange of the colonsocope and the defective device will be returned to EndoChoice.

    Distribution

    Worldwide Distribution. US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain and Switzerland.

    Quantity

    253 units