BEUDAMED
    FDA Recall Terminated

    MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System. MOSAIQ Oncology information system is owned and marketed by IMPAC Medical System, Inc. MOSAIQ is distributed by Siemens Medical Solutions USA, Inc, Radiation Oncology under a distributor contract with IMPAC Medical. Distributed by Siemens Healthcare, Concord, Ca. Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS, ONCOR and ARTISTE Solution family of linear accelerators systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. P

    Recall: Z-1270-2012 · Initiated February 14, 2012

    Recall

    Recall Number
    Z-1270-2012
    Event Number
    61308
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 14, 2012
    Posted
    March 21, 2012
    Terminated
    September 21, 2012
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System. MOSAIQ Oncology information system is owned and marketed by IMPAC Medical System, Inc. MOSAIQ is distributed by Siemens Medical Solutions USA, Inc, Radiation Oncology under a distributor contract with IMPAC Medical. Distributed by Siemens Healthcare, Concord, Ca. Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS, ONCOR and ARTISTE Solution family of linear accelerators systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. P

    Reason

    Images used in treatment planning may belong to another patient. Risk of treatment to wrong area. Software update to upgrade Siemens installed base to the latest release of MOSAIQ version 2.00X3 SP5, for RT Therapist version 2.1A

    Action

    Siemens sent a Customer Information letters to all affected customers. The Customer information letters inform customers of the release of MOSAIQ 2.00X3 SP5 which specifically addresses a safety issue that is only found when MOSAIQ is used with COHERENCE Therapist 2.1 MQ (also called RTT2.1A). This letter is to be kept with Customer information documentation. Update Instruction TH004/12S are being issued with the update. The Software update is delivered and installed by qualified Field Service Engineers. For questions, contact your responsible SIEMENS Service Engineer or Application Specialist.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of KY, PA, TN, WI, and P.R. and the countries of Australia, Belgium, Bosnia Herzeg. China, Colombia, Croatia, Czech Republic, Germany, India, Ireland, Japan, Lebanon, Malaysia, Mexico, New Zealand, Philippines, Poland, Russian Federation, South Africa, Saudi Arabia, Thailand, Turkey, and United Kingdom.

    Quantity

    44 affected Siemens Customers