BEUDAMED
    FDA Recall Terminated

    Mevatron K2, camera imaging system, Part Number: 1940753; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse, Kemnath, GERMANY, and SIEMENS AG, MEDICAL SOLUTIONS Henkestrasse, Erlangen, GERMANY The intended use of the SIEMENS branded linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    Recall: Z-2636-2011 · Initiated November 4, 2010

    Recall

    Recall Number
    Z-2636-2011
    Event Number
    58813
    Firm
    Siemens Medical Solutions USA, Inc Radiation Oncology
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 4, 2010
    Posted
    June 23, 2011
    Terminated
    November 14, 2011
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Mevatron K2, camera imaging system, Part Number: 1940753; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse, Kemnath, GERMANY, and SIEMENS AG, MEDICAL SOLUTIONS Henkestrasse, Erlangen, GERMANY The intended use of the SIEMENS branded linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    Reason

    The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.

    Action

    The firm, SIEMENS, sent a "Customer Information" letter to its customers on November 4, 2010. The letter describes the product, problem and actions to be taken. The customers were instructed to include this letter in their BEAMVIEW TI System Owner Manual chapter "Safety Advisory Letters" where it should remain. Siemens has developed an updated kit to install an additional grounding cable on the camera's central control unit to eliminate the problem. The updated kit was delivered with the Customer Information letter. If you have any questions, contact the Service Manager- Regulatory Affairs at 925-246-8407.

    Distribution

    Worldwide distribution: