BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL GAMMAPLAN

    MDR report key: 23877055 · Received December 23, 2025

    Report

    Report Number
    3015232217-2025-00063
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Report Date
    December 17, 2025
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    MUJ
    UDI-DI
    07340201502136
    PMA / PMN Number
    K232854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN ADMINISTRATIVE ERROR, THE REPORT WAS ORIGINALLY SUBMITTED UNDER ., WHICH WAS AN INCORRECT/INCOMPLETE REFERENCE NUMBER. THE CORRECT REFERENCE SHOULD HAVE BEEN .. THEREFORE, THIS REPORT HAS BEEN SUBMITTED AS AN INITIAL AND FINAL TO CORRECT THE REFERENCE NUMBER. H6 UPDATED. H11 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED THAT AN OBSOLETE STEREOTACTIC REFERENCE WAS USED FOR TREATMENT. IT WAS ASCERTAINED THAT A TREATMENT PLAN WAS CREATED USING FRAMELESS MRI IMAGES, G-FRAME FIXATION, AND CONE BEAM COMPUTED TOMOGRAPHY (CBCT) AS THE STEREOTACTIC REFERENCE. DURING THE PLANNING PROCESS, THE CUSTOMER ELECTED TO REPOSITION THE FRAME AND ACQUIRED A NEW CBCT. HOWEVER, DUE TO A USE ERROR, THE TREATMENT PLAN WAS NOT CORRECTLY UPDATED TO REFLECT THE NEW FRAME POSITION. AS A RESULT, THE TREATMENT WAS DELIVERED BASED ON THE PREVIOUS FRAME PLACEMENT. THE PLAN HAD BEEN APPROVED AND PARTIALLY DELIVERED BEFORE THE OPERATOR IDENTIFIED THE DISCREPANCY AND PAUSED THE TREATMENT. THE SYSTEM WORKED AS DESIGNED AND INTENDED. ELEKTA HAVE NOT BEEN PROVIDED WITH INFORMATION REGARDING THE PATIENT'S CONDITION. AN IMPORTANT FIELD SAFETY NOTICE (100-01-102-019) WILL BE SENT TO ALL AFFECTED CUSTOMERS FROM 17 DECEMBER 2025 (ELEKTA REFERENCE #: (B)(4)).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AN OBSOLETE STEREOTACTIC REFERENCE USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800762 LEKSELL GAMMAPLAN RADIONUCLIDE RT TREATMENT PLANNING SYSTEM MUJ ELEKTA SOLUTIONS AB 11.4.1 07340201502136

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown