BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated March 25, 2021

    Recall

    Recall Number
    Z-1427-2021
    Event Number
    87666
    Firm
    RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden
    FEI Number
    3007774465
    Product Code
    MUJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 25, 2021

    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.

    Action

    On 03/25/2021, RaySearch Laboratories issued an Urgent Medical Device Correction notice via email to their customer notifying them of an issue found with the display of flags in RayTreat. Flags edited in RayCare after a patient has been checked in, may not be updated in RayTreat.

    Distribution

    US Nationwide in the state of TN.

    Quantity

    1 system