BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEXION MEDICAL RADIOTHERAPY SYSTEM

    MDR report key: 24784106 · Received April 3, 2026

    Report

    Report Number
    3011716550-2026-00029
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 6, 2025
    Report Date
    April 3, 2026
    Manufacturer
    REFLEXION MEDICAL INC
    Product Code
    QVA
    UDI-DI
    00860003983812
    PMA / PMN Number
    DEN220014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A RECALL HAS BEEN FILED FOR THIS ISSUE ON 12-FEB-2026 (RES# 98518, RECALL NUMBER: Z-1656-2026, REFLEXION REPORT # 3011716550-02122026-C-00001) REFLEXION CONTINUES TO WORK WITH THE SITE TO COMPLETE THE INVESTIGATION INTO POTENTIAL EVENTS. REFLEXION HAS COMPLETED THE ROOT CAUSE INVESTIGATION FOR THE CAPA OPENED AND IS IN THE PROCESS OF IMPLEMENTING THE PROPOSED SOLUTION.

    Description of Event or Problem · 0

    DURING ROUTINE TESTING OF THE REFLEXION MEDICAL RADIOTHERAPY SYSTEM (RMRS) ON SITE AT REFLEXION, THE FOLLOWING FAILURE MODE WAS IDENTIFIED. WHEN PERFORMING ANGULAR ROLL CORRECTIONS FOLLOWED BY A REPEAT LOCALIZATION, THE ROLL CORRECTIONS APPLIED IN THE INITIAL LOCALIZATION SCAN ARE NOT CARRIED THROUGH TO TREATMENT DELIVERY LEADING TO THE TREATMENT PLAN DOSE BEING DELIVERED TO THE INCORRECT LOCATION. THIS WAS DETERMINED TO BE THE RESULT OF A SOFTWARE DEFECT ASSOCIATED WITH THE CALCULATION AND COMMUNICATION OF CUMULATIVE VIRTUAL ROLL OFFSETS BETWEEN COMPONENTS IN THE SYSTEM. IT WAS DETERMINED THAT A VERY SMALL NUMBER OF AFFECTED TREATMENT SESSIONS MAY HAVE A DISPLACEMENT OF AS MUCH AS 5MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME. A DISPLACEMENT OF 5MM OR HIGHER MAY RESULT IN CLINICALLY SIGNIFICANT DOSIMETRIC ERRORS (POTENTIALLY AS HIGH AS 10% TO 20% UNDERDOSE). FOR CASES OF POTENTIAL CONCERN WHERE THE DISPLACEMENT WAS BELOW 5MM, WE FURTHER EVALUATED THE POTENTIAL RISK OF POINT DOSE MISMATCH WITHIN THE DISPLACEMENT REGION. FOLLOWING ADDITIONAL INVESTIGATION AND DISCUSSIONS WITH THE SITE AND USING INFORMATION AVAILABLE IN THE SYSTEM LOGS TO INVESTIGATE THE IMPACT OF THE ABOVE PROBLEM, THE FOLLOWING CASE WAS IDENTIFIED HAVING A POTENTIAL RISK OF POINT DOSE MISMATCH OF GREATER THAN 20% WITHIN THE DISPLACEMENT REGION REPRESENTING A POTENTIALLY SIGNIFICANT DOSIMETRIC ERROR. THE PATIENT PLAN CONSISTED OF 12 GY TO BE DELIVERED IN 1 FRACTION. FOR THIS SPECIFIC CASE, A POTENTIAL POINT DOSE OF 30% WAS IDENTIFIED. THE SITE'S CLINICAL TEAM, WITH ACCESS TO ALL THE TREATMENT INFORMATION (E.G., DOSE DISTRIBUTION, TARGET LOCATION, PROXIMITY OF NEARBY ORGANS AT RISK, ETC.) EVALUATED THE CASE AND DETERMINED THAT NO ACTUAL SERIOUS INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844915 REFLEXION MEDICAL RADIOTHERAPY SYSTEM RXM1000 QVA REFLEXION MEDICAL INC RXM1000 00860003983812

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown