BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEXION MEDICAL RADIOTHERAPY SYSTEM

    MDR report key: 24527129 · Received March 5, 2026

    Report

    Report Number
    3011716550-2026-00003
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 6, 2026
    Manufacturer
    REFLEXION MEDICAL INC.
    Product Code
    QVA
    UDI-DI
    00860003983812
    PMA / PMN Number
    DEN220014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF A RECALL INVESTIGATION, A LOG REVIEW WAS COMPLETED TO IDENTIFY ALL SESSIONS THAT HAD A ROLL CORRECTION FOLLOWED BY A REPEAT LOCALIZATION TO DETERMINE THE NUMBER OF IMPACTED SESSIONS. SEE ATTACHED FILE FOR SESSIONS IMPACTED BY THE MALFUNCTION. ADDITIONAL INVESTIGATION IS ONGOING TO DETERMINE POTENTIAL ADVERSE EVENTS IN PATIENTS AND IDENTIFY NON-RELEVANT PHANTOM SESSIONS. A CAPA HAS BEEN INITIATED TO INVESTIGATE THE ROOT CAUSE.

    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 MOST AFFECTED TREATMENT SESSIONS WILL HAVE A DISPLACEMENT OF LESS THAN 1MM FROM THE INTENDED LOCATION FOR THE DELIVERED DOSE VOLUME; HOWEVER, 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). A RECALL HAS BEEN FILED FOR THIS ISSUE ON 12-FEB-2026 (RES# (B)(4), REFLEXION REPORT # (B)(4)). SEE H11 FOR ADDITIONAL INVESTIGATION INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584539 REFLEXION MEDICAL RADIOTHERAPY SYSTEM RXM1000 QVA REFLEXION MEDICAL INC. RXM1000 00860003983812

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown