BEUDAMED
    FDA Enforcement Class II Ongoing

    ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.

    Recall: Z-0472-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0472-2023
    Event ID
    91182
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2022
    Initiation Date
    November 9, 2022
    Classification Date
    December 9, 2022
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.

    Reason

    When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter

    Code Info

    UDI: N/A S/N: 10736, 10737, 10822, 10850, 10886,10843, 10865,10025 Software version 4.3.1 MR3

    Distribution

    US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.

    Quantity

    8 units US