BEUDAMED
    FDA Recall Terminated

    Drager Surgical Lights Sola 500 and Sola 700.

    Recall: Z-2212-2009 · Initiated August 26, 2009

    Recall

    Recall Number
    Z-2212-2009
    Event Number
    53135
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    FTD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 26, 2009
    Posted
    September 16, 2009
    Terminated
    March 8, 2010
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Drager Surgical Lights Sola 500 and Sola 700.

    Reason

    welded seam may fail

    Action

    Draeger Medical, Inc. issued a "Medical Device Recall" letter dated August 2009 via certified mail with return receipt. Consignees were informed on the affected product and that a service representative will be in contact shortly to schedule a replacement. For further information, contact Draeger Medical at 1-800-543-5047, press 1 at the prompt and then 2349.

    Distribution

    Nationwide Distribution -- IL, KY, and PA.

    Quantity

    20 units