BEUDAMED
    FDA Enforcement Class II Terminated

    SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.

    Recall: Z-0907-2013 · Reported March 13, 2013

    Enforcement

    Recall Number
    Z-0907-2013
    Event ID
    64214
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 13, 2013
    Initiation Date
    January 17, 2013
    Classification Date
    March 5, 2013
    Termination Date
    March 5, 2013
    Address
    4040 Nelson Ave, N/A, Concord, CA, 94520-1200, United States

    Description

    SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.

    Reason

    Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT 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

    All codes/units of ARTISTE model.

    Distribution

    5 devices, all located outside of the United States in Germany.

    Quantity

    5 units