BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEKSELL GAMMAPLAN

    MDR report key: 23423452 · Received October 30, 2025

    Report

    Report Number
    3015232217-2025-00069
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    February 25, 2025
    Report Date
    October 30, 2025
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    MUJ
    UDI-DI
    07340201502136
    PMA / PMN Number
    K232854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 0

    H11 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED A MISMATCH OF MR VS CBCT #2. AN AVM TREATMENT WAS PLANNED ON (B)(6) 2025 USING FRAME-BASED MRI AND ANGIO IMAGES FROM (B)(6) PLUS CURRENT CBCT IMAGES. THE CREATED PLAN WAS INCORRECTLY BASED ON THE NON-CURRENT FRAME-FIXATION FROM (B)(6) AND WAS NOT CORRECTLY UPDATED FOR THE CURRENT MASK FIXATION REPRESENTED BY THE CURRENT CBCT IMAGES. THE MISALIGNMENT WAS NOT DETECTED BY THE USER AND THE PLAN WAS APPROVED AND DELIVERED. THE ROOT CAUSE IS THAT THE PLAN WAS NOT PROPERLY UPDATED AFTER CHANGING FIXATION. THE CLEAR DISCREPANCIES THAT THIS CAUSED WERE NOT PROPERLY REVIEWED OR ACTED UPON BEFORE THE APPROVAL OF THE PLAN. 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) HAS BEEN SENT TO ALL AFFECTED CUSTOMERS FROM 17 DECEMBER 2025 (ELEKTA REFERENCE #: FCA-ESAB-0010). TO REDUCE THE LIKELIHOOD FOR ERRONEOUS USE OF OBSOLETE STEREOTACTIC REFERENCE FOR TREATMENTS WITH A FRAME, LEKSELL GAMMAPLAN® 11.5 WILL NO LONGER PERMIT THE USE OF STEREOTACTIC CBCT REFERENCE IN COMBINATION WITH OTHER STEREOTACTIC REFERENCES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A MISMATCH OF MR VS CBCT #2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251767 LEKSELL GAMMAPLAN RADIONUCLIDE RT TREATMENT PLANNING SYSTEM MUJ ELEKTA SOLUTIONS AB 11.4.1 07340201502136

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown