BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL GAMMAPLAN

    MDR report key: 23664380 · Received November 27, 2025

    Report

    Report Number
    3015232217-2025-00073
    Event Type
    Malfunction
    Date Received
    November 27, 2025
    Date of Event
    October 29, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IWB
    UDI-DI
    07340201502136
    PMA / PMN Number
    K232854
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 CUSTOMER REPORTED AN ISSUE WITH THE CBCT SYSTEM DURING CO-REGISTRATION WHERE SOMETIMES THE IMAGES DO NOT APPEAR AFTER ACQUISITION, OR ARE GETTING ASSIGNED TO THE WRONG PATIENT. AN INVESTIGATION WAS ATTEMPTED BY CONDUCTING AN EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE ISSUE COULD NOT BE REPRODUCED AND IT HAS NOT RECURRED AT THE CUSTOMER SITE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER WERE UNSUCCESSFUL. THE GAMMA KNIFE LOG FILE ANALYSIS DOES NOT SHOW ANY IRREGULARITIES CONCERNING THE CBCT IMAGE CREATION. THE LOGFILE CLEARLY INDICATES THAT THE CBCT IMAGES HAVE BEEN RECONSTRUCTED AND SHOWN. HOWEVER, OTHER HARDWARE RELATED PROBLEMS MAY PLAY A ROLE HERE WHICH WOULD NOT BE DETECTED BY LOG FILE ANALYSIS. HARDWARE RELATED PROBLEMS WOULD BE EXPECTED TO HAVE MORE SIGNIFICANT IMPACT THAN INDICATED BY THE CUSTOMER. REGARDING THE ISSUE WITH THE CBCT IMAGES BEING CONNECTED TO THE INCORRECT PATIENT, THIS HAS NOT BEEN POSSIBLE TO CONFIRM IN THE LOGFILES. NO INDICATIONS OF ANYTHING IRREGULAR HAVE BEEN FOUND. THE LOG FILE ANALYSIS INDICATE THAT THE SYSTEM IS WORKING AS INTENDED. IT HAS NOT BEEN POSSIBLE TO ESTABLISH THE ROOT CAUSE. THE RISK OF CBCT IMAGES BEING CONNECTED TO THE WRONG PATIENT IS A WELL-KNOWN RISK WITH MULTIPLE MITIGATIONS IN PLACE. THERE ARE NO INDICATIONS FROM THE LOG FILES THAT THE MITIGATIONS HAVE FAILED OR EVEN BEEN ACTIVATED. THE EXISTING RISKS ARE DEEMED ADEQUATELY MITIGATED. SINCE THE CBCT FUNCTIONALITY WAS RELEASED TO CUSTOMERS IN 2015 NO CASES OF CBCT IMAGES BEING CONNECTED TO THE WRONG PATIENT EXAMINATION IN LGP HAVE BEEN REPORTED. BASED ON AVAILABLE INFORMATION, THERE WAS NO MISTREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE WITH THE CBCT SYSTEM DURING CO-REGISTRATION WHERE SOMETIMES THE IMAGES DO NOT APPEAR AFTER ACQUISITION, OR ARE GETTING ASSIGNED TO THE WRONG PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3446 LEKSELL GAMMAPLAN RADIONUCLIDE RT TREATMENT PLANNING SYSTEM IWB ELEKTA SOLUTIONS AB 11.4.2 07340201502136

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown