BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEKTA INFINITY

    MDR report key: 24187913 · Received January 27, 2026

    Report

    Report Number
    9617016-2026-00002
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    May 1, 2025
    Report Date
    January 27, 2026
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    PMA / PMN Number
    K131965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN ADMINISTRATIVE OVERSIGHT, THE REPORT WAS ORIGINALLY SUBMITTED UNDER 3015232217-2025-00061, WHICH WAS AN INCORRECT MANUFACTURER NUMBER. THEREFORE, THIS REPORT HAS BEEN SUBMITTED AS AN INITIAL AND FINAL TO CORRECT THE MANUFACTURER. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. A THIRD-PARTY SUPPLIER ((B)(4)) NOTIFIED ELEKTA THAT A CUSTOMER REPORTED THAT A PATIENT WAS TREATED WITH A TABLE POSITION 20 CM OUT OF TOLERANCE. IT WAS ASCERTAINED THAT ON (B)(6) 2025, A PATIENT WAS TREATED WITH THE TREATMENT COUCH POSITION 20 CM OUT OF TOLERANCE. THE SITE USES A STANDARD TABLE CONFIGURATION. FOLLOWING IMAGING, THE TREATMENT COMPUTER FLAGGED A LONGITUDINAL MISALIGNMENT OF APPROXIMATELY 22 CM. THE THERAPIST MANUALLY APPLIED THE SHIFT POST-IMAGING. A DOSE OF -84 CGY WAS DELIVERED TO THE TARGET BEFORE THE MISALIGNMENT WAS IDENTIFIED. THIS REPRESENTS APPROXIMATELY 50% OF THE DAILY PRESCRIBED DOSE AND 1/50TH OF THE TOTAL PRESCRIPTION, WHICH IS CONSIDERED SERIOUS MISTREATMENT. THE LINAC FUNCTIONED AS DESIGNED AND INTENDED. THE SYSTEM CORRECTLY IDENTIFIED THE TABLE POSITION AS OUT OF TOLERANCE FOLLOWING IMAGING. THE USER IS RESPONSIBLE FOR MAKING SURE THAT THE PATIENT IS POSITIONED CORRECTLY. THE INCIDENT WAS ATTRIBUTED TO USE ERROR.

    Description of Event or Problem · 0

    THE THIRD-PARTY SUPPLIER ((B)(4)) NOTIFIED ELEKTA THAT THE CUSTOMER (MR (B)(6), (B)(6), EMAIL ADDRESS: (B)(6)) REPORTED THAT A PATIENT WAS TREATED WITH TABLE POSITION 20 CM OUT OF TOLERANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253757 ELEKTA INFINITY ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening