BEUDAMED
    FDA Recall Terminated

    OR table TITAN UT, Surgical Table. Surgical bed with Orthopedic Accessories.

    Recall: Z-0398-2012 · Initiated January 21, 2011

    Recall

    Recall Number
    Z-0398-2012
    Event Number
    60440
    Firm
    Trumpf Medical Systems, Inc.
    FEI Number
    3003184737
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 21, 2011
    Posted
    January 11, 2012
    Terminated
    August 13, 2012
    Address
    415 Jessen Ln, Charleston, SC, 29492

    Description

    OR table TITAN UT, Surgical Table. Surgical bed with Orthopedic Accessories.

    Reason

    Product is being recalled due to unintended movement on the Titan Tables.

    Action

    Trumpf Medical Systems sent an initial notification to customers dated January 24, 2011. A subsequent "URGENT SAFETY NOTICE-UPDATE" letter dated May 26, 2011 was sent to all affected customers. The letter described the product, problem, and actions to be taken by the customers. A Corrective Action Plan includes a software update to be installed by a Trumpf Technical Service Representative. Contact Technical Service at 888-474-9359 for questions regarding this notice.

    Distribution

    Worldwide Distribution.

    Quantity

    see line 1.