BEUDAMED
    FDA Recall Terminated

    ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K

    Recall: Z-1122-2009 · Initiated February 27, 2009

    Recall

    Recall Number
    Z-1122-2009
    Event Number
    51236
    Firm
    Trumpf Medical Systems, Inc.
    FEI Number
    3003184737
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 27, 2009
    Posted
    April 1, 2009
    Terminated
    October 22, 2009
    Address
    415 Jessen Ln, Charleston, SC, 29492

    Description

    ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K

    Reason

    Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area.

    Action

    Consignees were notified via an Urgent Safety Information letter starting 02/27/2009. The Recall Notice asks customers to visually inspect the ILED covers for cracks and in particular to focus on the corners. If cracking is visible they are asked to remedy by taping with a clear tape over the cracks and report it to TRUMPF Medical Systems, Inc. immediately. TRUMPF will be replacing all covers with a newly designed and tested cover. Original priority in the United States will be set to start with the oldest units affected. If TRUMPF receives notification that cracking does exist then that facility will rise to the highest priority. Additionally, TRUMPF will issue a new approved cleaning and disinfection instruction, since investigations have shown that the cracking is significantly influenced by the use of certain disinfectants containing alcohol. The operator manual previously stated to avoid using alcohol-based cleaners on some parts of the ILED, but after reviewing this it was determined that it was not clearly stated to avoid use on the covers.

    Distribution

    Worldwide Distribution.

    Quantity

    4480 units (540 in U.S.)