BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA HD

    MDR report key: 25170442 · Received May 14, 2026

    Report

    Report Number
    3015232217-2026-00012
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    PMA / PMN Number
    K210500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING DATE IS NOT ON THE LABEL AS PI, BUT IT IS KNOWN SO FIELD H4 HAS BEEN COMPLETED WITH THIS INFORMATION. THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ELECTRICAL SAFETY INCIDENT INVOLVING A HOSPITAL ENGINEER DURING A SCHEDULED PREVENTIVE MAINTENANCE (PM) PROCEDURE. THE INCIDENT RESULTED IN A LOCALIZED SKIN BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49126 VERSA HD ACCELERATOR, LINEAR, MEDICAL, IYE ELEKTA SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other