BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEKTA SYNERGY

    MDR report key: 25054841 · Received May 1, 2026

    Report

    Report Number
    3015232217-2026-00011
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 1, 2026
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    PMA / PMN Number
    K051932
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A YELLOW CARD 2026/003/031/501/013 WAS RECEIVED FROM THE MHRA. THE REPORTS STATES THAT THE FRAMES HAVE A STRANGE APPEARANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212940 ELEKTA SYNERGY ACCELERATOR, LINEAR, MEDICAL IYE

    Patients

    Seq Age Sex Outcome Treatment
    1