BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EOS IMAGING

    MDR report key: 24714220 · Received March 30, 2026

    Report

    Report Number
    3006165260-2026-00002
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    January 29, 2026
    Report Date
    March 27, 2026
    Manufacturer
    EOS IMAGING
    Product Code
    KPR
    UDI-DI
    03663999000399
    PMA / PMN Number
    K233920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXAMINATION INVOLVED LARGER FIELDS, WHICH EXPLAINS WHY THE DISPLAYED DOSE WAS HIGHER THAN EXPECTED FOR A SIMPLE ARM ACQUISITION. IT WAS DETERMINED THAT THE DOSE RECEIVED BY THE PATIENT WAS 3.3 TIMES THE HIGH ESTIMATE OF THE EXPECTED DOSE FOR AN AUTO MODE EXAMINATION WITHOUT THE FLEX DOSE FEATURE, BASED ON THE EXPOSURE PARAMETERS USED BY EOS IMAGING. AS SUCH, THE ADDITIONAL DOSE RECEIVED BY THE PATIENT WAS 0.73 MGY. THE INVESTIGATION REVEALED NO MALFUNCTION OF THE EOSEDGE SYSTEM, NOR ANY ANOMALY IN THE ESTIMATION OR DISPLAY OF THE DOSE. THE SYSTEM PROTOCOLS WERE COMPLIANT, WITH NO CONFIGURATION ERRORS. THE DOSE VALUES RECORDED IN THE LOGS CORRESPOND TO THE ACQUISITIONS PERFORMED. THE DIFFERENCE BETWEEN THE DISPLAYED DOSES AND THE DOSES EXPECTED BY THE RADIOGRAPHER IS THEREFORE NOT DUE TO A TECHNICAL, SOFTWARE, OR CALIBRATION PROBLEM WITH THE EOSEDGE SYSTEM.

    Description of Event or Problem · 0

    ON FEBRUARY 26, 2026, UPON RECEIVING IMAGES AND LOGS FOR THE INVESTIGATION OF A COMPLAINT RELATED TO A PATIENT WHO RECEIVED AN ABNORMALLY HIGH DOSE OF X-RAYS ((B)(6)), EOS IMAGING NOTED THAT ANOTHER PATIENT HAD ALSO RECEIVED AN ABNORMALLY HIGH DOSE AS PART OF AN "ARM" PROTOCOL. THE DOSE RECORDED FOR THE RIGHT ARM IN THE FRONTAL VIEW WAS 1043.53 MGY.CM², WHILE THAT FOR THE LEFT ARM IN THE PROFILE VIEW WAS ONLY 170.55 MGY.CM².

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778318 EOS IMAGING EOSEDGE KPR EOS IMAGING 3.1.0 03663999000399

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Unknown Other