BEUDAMED
    FDA Recall Terminated

    Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufactured and distributed by Siemens AG, Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany 95478. The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to position the patient accurately according to the treatment plan for various radiation therapy treatment techniques.

    Recall: Z-2023-2011 · Initiated March 31, 2010

    Recall

    Recall Number
    Z-2023-2011
    Event Number
    55577
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    JAI
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 31, 2010
    Posted
    April 19, 2011
    Terminated
    March 1, 2012
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufactured and distributed by Siemens AG, Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany 95478. The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to position the patient accurately according to the treatment plan for various radiation therapy treatment techniques.

    Reason

    Potential for causing overheating of the power supply during treatment, and potential for unexpected table descent.

    Action

    Siemens issued a Customer Information letter dated March 21, 2010. There were two safety issues. There were two occurrences of smoke caused by an overheating of the power supply during patient treatment. Also, there had been a report of an unexpected lowering of the 550TxT table in patient rescue mode. With the released kit that accompanies this letter, Siemens has implemented a minor modification on the 550TxT to include an additional fuse within the power supply circuit to address the first issue described above. They also included an additional modification to address the lowering of the table by the integration of additional relays. As soon as the "move enable" button is released, the table brake will be enabled which is controlled by the implemented relays. No further action is required for the continued operations of the 550TxT table. Further questions regarding this recall please call (925) 246-8407

    Distribution

    Worldwide Distribution -- Including USA, states of NJ, WI, NY, and MA.

    Quantity

    326 units