BEUDAMED
    FDA Recall Completed

    Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5

    Recall: Z-0563-2016 · Initiated November 2, 2015

    Recall

    Recall Number
    Z-0563-2016
    Event Number
    72542
    Firm
    Trumpf Medical Systems, Inc.
    FEI Number
    3003184737
    Product Code
    FSY
    Status
    Completed
    Root Cause
    Other
    Initiated
    November 2, 2015
    Address
    1046 Legrand Blvd, Charleston, SC, 29492-7672

    Description

    Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5

    Reason

    The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.

    Action

    TRUMPF sent an " Urgent Field Safety Information" letter dated December 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the customer: 1. Perform an inspection of the lighting systems (see Appendix 1 for instructions). If any of the symptoms listed below are observed, immediately remove the light from operation and contact your Trumpf Medical Service Representative or designee. Signs that indicate a possible fall of the spring arm: The movement of the light and spring arm is difficult for the user, The lights have stopped being operational, and/or A gap is noticed between the spring arm and the central axis (see the attached Appendix 1 for an example). 2. Follow the User Manual: No unauthorized servicing of the spring arm is permitted. Snap rings are one use only and replacements must be purchased from your authorized Trumpf Medical partner. If you have any questions concerning this request or the procedure as outlined, please contact TRUMPF Medical Systems, Inc. at 888-474-9359

    Distribution

    USA (nationwide) Distribution to the states of : AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KY, ME, MA, MN, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WY., and Internationally to Canada.

    Quantity

    20,713