BEUDAMED
    FDA Enforcement Class II Terminated

    PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.

    Recall: Z-1402-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1402-2018
    Event ID
    79766
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 25, 2018
    Initiation Date
    February 14, 2018
    Classification Date
    April 17, 2018
    Termination Date
    May 16, 2019
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.

    Reason

    Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.

    Code Info

    Serial no: 2958 3832 3241 3574 3519 3922 3924 3361 4036 3302 70-4185 3949 3547 3657 3622 3731 3565 5153

    Distribution

    Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.

    Quantity

    18