BEUDAMED
    FDA Adverse Event Other Summary report: N

    GM85

    MDR report key: 22469749 · Received July 10, 2025

    Report

    Report Number
    3004938766-2025-00022
    Event Type
    Other
    Date Received
    July 10, 2025
    Date of Event
    June 11, 2025
    Report Date
    July 10, 2025
    Manufacturer
    SAMSUNG ELECTRONICS CO., LTD.
    Product Code
    IZL
    Report Source
    Distributor report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A USER ERROR WAS REPORTED WHEN THE TUBE WAS ROTATED AWAY FROM THE DETECTOR AFTER THE FIRST EXPOSURE, RESULTING IN A RE-EXPOSURE AND A DELAY IN THE PATIENT'S PROCEDURE. USER EDUCATION WAS PROVIDED AS A CORRECTIVE ACTION. THERE WERE NO REPORTS OF PATIENT HARM. IF ADDITIONAL INFORMATION ARISES, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE PATIENT PROCEDURE WAS DELAYED, AND RE-EXPOSURE WAS REQUIRED DUE TO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602085 GM85 DIGITIAL DIAGNOSTIC X-RAY SYSTEM IZL SAMSUNG ELECTRONICS CO., LTD. DGR2ABA1BBNN1W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown