BEUDAMED
    FDA Enforcement Class II Terminated

    ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    Recall: Z-2073-2012 · Reported August 1, 2012

    Enforcement

    Recall Number
    Z-2073-2012
    Event ID
    62519
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2012
    Initiation Date
    June 25, 2012
    Classification Date
    July 24, 2012
    Termination Date
    October 18, 2012
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200, United States

    Description

    ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    Reason

    Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments. In a very rare scenario, the RT Therapist will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.

    Code Info

    ARTISTE, Part #: 08139789, ONCOR Avant Garde, Part #: 05863472, ONCOR Impression Plus, Part #: 05857912, ONCOR Expression, Part #: 07360717

    Distribution

    Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea.

    Quantity

    18