BEUDAMED
    FDA Enforcement Class II Terminated

    RayStation 9B SP1. For radiation treatment planning.

    Recall: Z-1403-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1403-2022
    Event ID
    90498
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 27, 2022
    Initiation Date
    June 1, 2022
    Classification Date
    July 19, 2022
    Termination Date
    October 4, 2023
    Address
    Sveavagen 9, N/A, Stockholm, N/A, N/A, Sweden

    Description

    RayStation 9B SP1. For radiation treatment planning.

    Reason

    An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.

    Code Info

    UDI-DI: 0735000201029720200310 Build number 9.2.0.483

    Distribution

    Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.

    Quantity

    1