BEUDAMED
    FDA Enforcement Class II Terminated

    RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs

    Recall: Z-1598-2021 · Reported May 26, 2021

    Enforcement

    Recall Number
    Z-1598-2021
    Event ID
    87868
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 26, 2021
    Initiation Date
    April 7, 2021
    Classification Date
    May 14, 2021
    Termination Date
    June 2, 2023
    Address
    Sveavagen 9, N/A, Stockholm, N/A, N/A, Sweden

    Description

    RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs

    Reason

    When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.

    Code Info

    Software version number: 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 , 10.1.0.613

    Distribution

    Domestic: TN

    Quantity

    N/A