BEUDAMED
    FDA Enforcement Class II Terminated

    ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

    Recall: Z-2812-2015 · Reported September 30, 2015

    Enforcement

    Recall Number
    Z-2812-2015
    Event ID
    71915
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 30, 2015
    Initiation Date
    August 5, 2015
    Classification Date
    September 23, 2015
    Termination Date
    September 1, 2016
    Address
    40 Liberty Blvd, Mail Code: 65-1A, Malvern, PA, 19355-1418, United States

    Description

    ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

    Reason

    A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.

    Code Info

    ARTISTE - 08139789 ONCOR Avantgarde - 05863472 ONCOR Impression Plus - 05857912 ONCOR Expression  07360717 PRIMUS - K993425 PRIMUS Plus  04504200 Syngo RT Therapist - 08162815 serial numbers: 5177 3761 3981 3998 5096 70-4161 3354 10570 10793 10794 10796 10795 10798 10814 10792 5300 10046 10549 10687 3624 5350 5784 10586 5830 10010 5419

    Distribution

    Worldwide Distribution and US Nationwide

    Quantity

    26