BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 23663637 · Received November 27, 2025

    Report

    Report Number
    3007774465-2025-00003
    Event Type
    Malfunction
    Date Received
    November 27, 2025
    Date of Event
    November 7, 2025
    Report Date
    November 27, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K240398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN RAYSTATION, THE USER CAN DEFINE VOLUMES, REGIONS OF INTEREST, ROIS, WHERE THE IMAGE DATA USED FOR DOSE CALCULATION IS OVERRIDDEN WITH A BULK DENSITY ASSIGNMENT. THIS IS CALLED MATERIAL OVERRIDE, MO, AND MAY BE REQUIRED WHEN THE PATIENT HAS IMPLANTS OF MATERIALS THAT ARE NOT WELL REPRESENTED IN THE IMAGE DATA OR WHEN THERE ARE ARTIFACTS IN THE IMAGES. USING MATERIAL OVERRIDE IN SUCH SITUATIONS IMPROVES THE DOSE CALCULATION ACCURACY. IF THE DOSE CALCULATION DOES NOT CORRECTLY TAKE INTO ACCOUNT THE MO ROIS DEFINED, THE ESTIMATED RADIATION DOSE CALCULATED BY RAYSTATION MAY DIFFER FROM THE DELIVERED DOSE. IN RARE CASES, THE CALCULATED RADIATION DOSE IS NOT INVALIDATED AS INTENDED WHEN A GEOMETRY IS ADDED OR CHANGED OR MO IS REMOVED FOR AN ROI THAT HAS A MO DEFINED OR IS OF TYPE BOLUS, FIXATION OR SUPPORT. THIS CAN OCCUR ONLY FOR AN ROI THAT HAS A PRIMARYSHAPE , BUT NO CONTOURS. THIS CAN BE THE CASE, E.G., IF ALL CONTOURS HAVE BEEN DELETED OR IF A DERIVED ROI IS CREATED AND RESULTS IN AN EMPTY GEOMETRY. WHEN CONTOURS ARE ADDED OR CHANGED FOR SUCH AN ROI, DOSE IS NOT INVALIDATED. THE TREATMENT PLAN CAN BE APPROVED AND EXPORTED WITH THE DOSE IN THIS INCONSISTENT STATE.

    Description of Event or Problem · 0

    A USER HAS REPORTED THAT DURING WHEN WORKING ON A TREATMENT PLAN, THEY NOTICED THAT THE CALCULATED RADIATION DOSE WAS NOT INVALIDATED AS EXPECTED WHEN THEY CHANGED THE PROPERTIES OF A REGION OF INTEREST, ROI. THERE WAS NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2744755 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) 10B-V2025 SP1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown