BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EOS IMAGING

    MDR report key: 24618912 · Received March 17, 2026

    Report

    Report Number
    3006165260-2026-00001
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    January 29, 2026
    Report Date
    March 17, 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

    AN ANALYSIS OF THE IMAGES (IMDRF TYPE OF INVESTIGATION B30: ANALYSIS OF THE IMAGES), A REVIEW OF THE LABELLING (IMDRF TYPE OF INVESTIGATION B31: LABELLING REVIEW), AND AN EXAMINATION OF THE LOG FILES RETRIEVED FROM THE SYSTEM LED TO THE CONCLUSION THAT NO TECHNICAL ANOMALIES WERE IDENTIFIED. THE ACQUISITION CHAIN WAS OPERATING NORMALLY, AND THE APPLIED PARAMETERS WERE CONSISTENT WITH THE DEVICE'S SPECIFICATIONS. THE EXAMINATION INVOLVED SIGNIFICANTLY LARGER FIELD SIZES AND ACQUISITION TIMES, EXPLAINING WHY THE DOSE DISPLAYED WAS MUCH HIGHER THAN EXPECTED FOR A SIMPLE ARM ACQUISITION. IT HAS BEEN DETERMINED THAT THE ADDITIONAL DOSE RECEIVED BY THE PATIENT IS 2.76 MGY COMPARED TO A HIGH ESTIMATE OF THE EXPECTED DOSE FOR AN AUTO MODE EXAMINATION WITHOUT THE FLEX DOSE FUNCTION BASED ON THE EXPOSURE PARAMETERS USED BY EOS IMAGING. THE INVESTIGATION DID NOT IDENTIFY ANY MALFUNCTION OF THE EOSEDGE SYSTEM, NOR ANY ANOMALY IN THE ESTIMATION OR DISPLAY OF THE DOSE. THE PROTOCOLS ON THE SYSTEM WERE COMPLIANT, WITH NO CONFIGURATION ERRORS. THE DOSE VALUES RECORDED IN THE LOGS CORRESPOND TO THE ACQUISITIONS ACTUALLY 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 (B)(6)2026, AT LYON UNIVERSITY HOSPITAL, NINON MARY, A RADIOLOGY TECHNICIAN, SENT AN EMAIL TO (B)(6), REPORTING UNUSUALLY HIGH DOSE LEVELS DURING A LEG EXAMINATION PERFORMED ON A NINE-YEAR-OLD CHILD USING THE EOSEDGE SYSTEM, INSTALLED ON (B)(6)2025. USING THE "LEG" PROTOCOL, THE DOSES DISPLAYED WERE 2306.28 MGY·CM² FOR THE FRONT VIEW AND 3261.90 MGY·CM² FOR THE SIDE VIEW.IN COMPARISON, FOR A PATIENT OF SIMILAR AGE EXAMINED ON A STEPHANIX SYSTEM, THE RECORDED DOSE WAS 5.39 MGY·CM² PER INCIDENCE. THE VERY SIGNIFICANT DIFFERENCE BETWEEN THE TWO DEVICES LED TO QUESTIONS ABOUT THE VALIDITY, CONFIGURATION, OR COMPLIANCE OF THE BONE PROTOCOLS USED ON EOSEDGE. THE SITE IS THEREFORE REQUESTING CLARIFICATION ON THE VALIDATION OF THE PROTOCOLS AND THE POTENTIAL ORIGIN OF THESE HIGH DOSE VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676478 EOS IMAGING EOSEDGE KPR EOS IMAGING 3.1.0 03663999000399

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male Other