BEUDAMED
    FDA Enforcement Class II Terminated

    Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment fields and recording the delivered treatment. Treatstation supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, Lantis Treatstation supports intensity modulation, a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.

    Recall: Z-2197-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2197-2019
    Event ID
    83462
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2019
    Initiation Date
    July 10, 2019
    Classification Date
    August 6, 2019
    Termination Date
    June 3, 2020
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment fields and recording the delivered treatment. Treatstation supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, Lantis Treatstation supports intensity modulation, a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.

    Reason

    Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability

    Code Info

    Serial # 93-0759 93-0648 93-0662 93-1045 93-0574 93-0313 93-0501 93-0951 93-0667 93-0141 93-0786 93-0385 93-0799 93-0659 93-0861 ***added 8/14/19*** 93-0159 93-0878 93-0272 93-0596

    Distribution

    State WV NY PA FL OK FL NJ NY IL WY NY GA NY PA PA AL NJ NY ***updated 8/14/19*** OH NC

    Quantity

    15