BEUDAMED
    FDA Enforcement Class II Terminated

    ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.

    Recall: Z-0984-2015 · Reported March 25, 2015

    Enforcement

    Recall Number
    Z-0984-2015
    Event ID
    69880
    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 25, 2015
    Initiation Date
    November 19, 2014
    Classification Date
    March 18, 2015
    Termination Date
    April 28, 2015
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406, United States

    Description

    ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.

    Reason

    There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.

    Code Info

    Model number: 08139789, serial numbers: 5419, 5784, 5830

    Distribution

    US Distribution to the states of UT, WI, and NY.

    Quantity

    3