BEUDAMED
    FDA Recall Terminated

    Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

    Recall: Z-0077-2013 · Initiated September 19, 2012

    Recall

    Recall Number
    Z-0077-2013
    Event Number
    63255
    Firm
    Trumpf Medical Systems, Inc.
    FEI Number
    3003184737
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 19, 2012
    Posted
    October 18, 2012
    Terminated
    January 21, 2014
    Address
    415 Jessen Ln, Charleston, SC, 29492

    Description

    Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

    Reason

    Incidents regarding fractures of the front joint of the spring arm have been reported.

    Action

    Trumpf sent an "URGENT RECALL NOTICE" dated September 19, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Confirmation of Receipt Form was attached for customers to complete and return. Contact the firm at 888-474-9359 for questions regarding this notice.

    Distribution

    Nationwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT and WI.

    Quantity

    275 units