BEUDAMED
    FDA Recall Terminated

    Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp

    Recall: Z-0358-04 · Initiated January 9, 2004

    Recall

    Recall Number
    Z-0358-04
    Event Number
    28101
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    FTD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 9, 2004
    Posted
    January 22, 2004
    Terminated
    August 19, 2004
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp

    Reason

    adjustment screw may break due to material fatigue

    Action

    The recalling firm issued a recall letter dated 1/9/03 to their direct accounts. The recall letter informed the accounts of the problem, the potential danger, and that they will be contacted to schedule replacement.

    Distribution

    Nationwide and Canada. The products were shipped to medical facilities in CA, CO, FL, GA, IL, IN, KS, MO, NC, NV, OH, TX, and VA. The product was also shipped to a medical facility in Canada.

    Quantity

    51 units