BEUDAMED
    FDA Enforcement Class II Terminated

    Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs

    Recall: Z-1815-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1815-2017
    Event ID
    76342
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    January 18, 2017
    Classification Date
    April 12, 2017
    Termination Date
    June 12, 2019
    Address
    Sveavaegen 9, N/A, Stockholm, N/A, N/A, Sweden

    Description

    Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs

    Reason

    An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citrix graphics board (graphics card) an erroneous calculation may be allowed.

    Code Info

    4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11, 5.0.2.35

    Distribution

    Nationwide Distribution to AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, LA, MN, MD, MA, MI, MS, MT, NJ, NY, NC, NV, OH, OK, OR, PA, RI, TN, TX, VA, VT, VI, WA, WI, and Washington D.C.

    Quantity

    741 units