BEUDAMED
    FDA Recall Terminated

    Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Part No. 8168754, Distributed by Siemens Medical Solutions Oncology Care System, Concord CA Medical charged-particle radiation therapy system. 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-1523-2011 · Initiated June 29, 2010

    Recall

    Recall Number
    Z-1523-2011
    Event Number
    56344
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 29, 2010
    Posted
    March 4, 2011
    Terminated
    March 9, 2012
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Part No. 8168754, Distributed by Siemens Medical Solutions Oncology Care System, Concord CA Medical charged-particle radiation therapy system. 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

    A software problem that has the potential for data loss during the transfer of treatment records to the OIS, which may not be recorded in MOSAIQ, and subsequently may lead to mistreatment.

    Action

    Siemens sent Urgent Medical Device Correction, Safety Advisory Notices to all affected customers on June 29, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the Safety Advisory Notice in their System Owner Manual, Chapter, "Safety Advisory Letter. For questions customers were instructed to contact their Siemens Service Engineer or Application Specialist. For questions regarding this recall call 925-602-8157.

    Distribution

    Worldwide Distribution - USA including NC,OH, and the countries of Belgium, Sweden, Germany, Lebanon, Japan, Australia, and Iran.