BEUDAMED
    FDA Recall Terminated

    PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    Recall: Z-0787-2014 · Initiated December 5, 2013

    Recall

    Recall Number
    Z-0787-2014
    Event Number
    67126
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    JAI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 5, 2013
    Posted
    January 17, 2014
    Terminated
    January 30, 2015
    Address
    757 Arnold Dr, Ste A, Martinez, CA, 94553-3615

    Description

    PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    Reason

    Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT Treatment Table. Combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the TxT" Treatment Table has been damaged due to contacting a moving part. The resulting short-circuit cau

    Action

    The firm, Siemens, sent a "Medical Device Correction" letter to affected users/customers starting on December 5, 2013 via Federal express. The letter described the product, problem and actions to be taken. Siemens has arranged for modification of the affected 500 TxT Treatment Table. A service representative will modify the mounts of the TT-A, TT-D, TT-M, or TT-s table tops ( Pleases note that this modification only applies to the Siemens provided table tops TT-A, TT-D, TT-M, and TT-S.). In addition, the Siemens service representative will modify the cable routing inside of the patient table base. The customers were instructed to include this Field Safety Notice in your Digital Linear Accelerator System Owner manual chapter 'Safety Advisory Letters' where it should remain. If you have any questions, please contact the Senior Manager, Regulatory Affairs at 1-925-293-5442 or email: [email protected].

    Distribution

    Worldwide Distribution: US (nationwide) and internationally to: Canada, Italy, P.R. China, Argentina, Pakistan, South Africa, Egypt, Iran, Vietnam, Indonesia, Brazil, Hungary, Bulgaria, India, Spain, Switzerland, Trinidad, Tobago, Italy, Algeria, Croatia, Turkey, Japan, Germany, Portugal, Poland, France, Sri Lanka, Russian Federation, France, Lebanon, Slovakia, Ukraine, Pakistan, and Korean Republic.

    Quantity

    305 active devices.