BEUDAMED
    FDA Enforcement Class II Terminated

    RayStation Product Usage: 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.

    Recall: Z-0380-2018 · Reported January 24, 2018

    Enforcement

    Recall Number
    Z-0380-2018
    Event ID
    78900
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 24, 2018
    Initiation Date
    July 17, 2017
    Classification Date
    January 16, 2018
    Termination Date
    August 29, 2018
    Address
    Sveavaegen 9, N/A, Stockholm, N/A, N/A, Sweden

    Description

    RayStation Product Usage: 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.

    Reason

    For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.

    Code Info

    6.0.0.24 , 6.1.0.26 , 6.1.1.2 or 6.2.0.7

    Distribution

    US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.

    Quantity

    117 units