BEUDAMED
    FDA Recall Terminated

    Siemens Biograph mCt-X, model number 10248670. Medical Imaging Equipment.

    Recall: Z-0162-2010 · Initiated August 11, 2009

    Recall

    Recall Number
    Z-0162-2010
    Event Number
    53453
    Firm
    Siemens Medical Solutions USA Inc.
    FEI Number
    1034973
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 11, 2009
    Posted
    November 10, 2009
    Terminated
    December 22, 2009
    Address
    810 Innovation Dr, Knoxville, TN, 37932-2562

    Description

    Siemens Biograph mCt-X, model number 10248670. Medical Imaging Equipment.

    Reason

    In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.

    Action

    Siemens Medical Solutions USA, Inc. issued an "Urgent Field Correction - Recall" notice to consignees by letter dated September 3, 2009 informing them of the problem and that a Siemens service representative will be in contact shortly to service the affected product. For further information, contact Siemens at 1-800-888-7436.

    Distribution

    Worldwide Distribution -- United States (IL and OH), Germany, France and Hong Kong.

    Quantity

    3 units