BEUDAMED
    FDA Recall Terminated

    Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 1940753, Siemens Medical Solutions, Concord, CA 94520

    Recall: Z-0685-2008 · Initiated August 7, 2007

    Recall

    Recall Number
    Z-0685-2008
    Event Number
    46157
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 7, 2007
    Posted
    February 14, 2008
    Terminated
    December 1, 2010
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 1940753, Siemens Medical Solutions, Concord, CA 94520

    Reason

    Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.

    Action

    The firm has sent consignees a Customer Safety Advisory Notice on August 7, 2007 informing them that a misplacement of the X and/or Y jaws can occur if interlock #51 Jaw Field Position is asserted and then cleared with the left-hand key rest. The firm recommends that if an interlock issue is encountered tha treatment of the patient be discontined until this issue is resolved.

    Distribution

    Worldwide Distribution

    Quantity

    59 units