BEUDAMED
    FDA Enforcement Class II Ongoing

    RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)

    Recall: Z-1427-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1427-2021
    Event ID
    87666
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 21, 2021
    Initiation Date
    March 25, 2021
    Classification Date
    April 15, 2021
    Address
    Sveavagen 9, N/A, Stockholm, N/A, N/A, Sweden

    Description

    RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)

    Reason

    Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.

    Code Info

    Software version: 9A, 9B, 10A, 10B

    Distribution

    US Nationwide in the state of TN.

    Quantity

    1 system