BEUDAMED
    FDA Enforcement Class II Ongoing

    RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.

    Recall: Z-2899-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2899-2020
    Event ID
    86249
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 2, 2020
    Initiation Date
    July 29, 2020
    Classification Date
    August 27, 2020
    Address
    Sveavagen 9, N/A, Stockholm, N/A, N/A, Sweden

    Description

    RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.

    Reason

    When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.

    Code Info

    Model #: 2C SP2, 2C SP3, 3A SP1, 3B and 4A Software Version: 2.2.2.30782 , 2.2.3.53423 , 3.0.1.43597 , 3.1.0.60341 , 4.0.0.60621"

    Distribution

    US Nationwide distribution including in the state of Tennessee.

    Quantity

    N/A