BEUDAMED
    FDA Enforcement Class II Terminated

    RayStation 11B

    Recall: Z-1299-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1299-2022
    Event ID
    90505
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 6, 2022
    Initiation Date
    June 10, 2022
    Classification Date
    June 28, 2022
    Termination Date
    June 11, 2024
    Address
    Sveavagen 9, Stockholm, N/A, Sweden

    Description

    RayStation 11B

    Reason

    This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.

    Code Info

    UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68

    Distribution

    US Nationwide distribution in the states of NJ and TX.

    Quantity

    26