BEUDAMED
    FDA Enforcement Class II Ongoing

    RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2

    Recall: Z-2426-2020 · Reported July 1, 2020

    Enforcement

    Recall Number
    Z-2426-2020
    Event ID
    85796
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 1, 2020
    Initiation Date
    May 26, 2020
    Classification Date
    June 24, 2020
    Address
    Sveavagen 9, N/A, Stockholm, N/A, N/A, Sweden

    Description

    RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2

    Reason

    It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.

    Code Info

    Software versions 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 and 9.2.0.483

    Distribution

    Distributed to one consignee in Nashville. Foreign distribution to one consignee in Belgium.

    Quantity

    12