BEUDAMED
    FDA Enforcement Class II 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 · Reported October 24, 2012

    Enforcement

    Recall Number
    Z-0077-2013
    Event ID
    63255
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trumpf Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 24, 2012
    Initiation Date
    September 19, 2012
    Classification Date
    October 18, 2012
    Termination Date
    January 21, 2014
    Address
    415 Jessen Ln, N/A, Charleston, SC, 29492, United States

    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.

    Code Info

    Ondal AC2000 serial range of the spring arms requiring rework: 0111 010 xxxxxx to 0111 066 xxxxx (010 to 066 = month 01/year 20000 to month 06/year 2006 xxxxxx = 5 digit serial number).

    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