BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 23208075 · Received October 3, 2025

    Report

    Report Number
    3015232217-2025-00066
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 2, 2025
    Report Date
    March 16, 2026
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    PMA / PMN Number
    K183034
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6 UPDATED. H11 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED THAT THE CBCT (CONE BEAM COMPUTED TOMOGRAPHY) TIME STAMPS APPEAR TO BE SWITCHED. IT WAS ASCERTAINED FROM THE LOGS THAT THE FIRST CBCT AND IMAGE REGISTRATION WAS PERFORMED. THE CUSTOMER NOTICED A LARGE SHIFT IN THE REGISTRATION, SO THEY CANCELLED (HIT CANCEL) AND TOOK ANOTHER CBCT. THE CUSTOMER THEN PERFORMED IMAGE REGISTRATION ON THE SECOND CBCT, CLICKED SAVE MATCH AND PROCEEDED TO COMPLETE THE TREATMENT. THIS IS A NON-RECOMMENDED WORKFLOW. THE RECOMMENDED AND SUPPORTED WORKFLOW FOR CBCT IS AFTER TAKING THE IMAGE AND PERFORMED IMAGE REGISTRATION THEN CLICK SAVE MATCH. AFTERWARDS, THEY CAN CLICK CANCEL AND TAKE ANOTHER CBCT, PERFORM IMAGE REGISTRATION AND CLICK SAVE MATCH AGAIN. THE SAVE MATCH IS TO NOTIFY TRUEBEAM TO RIGHT AWAY SEND BACK TO MOSAIQ THE ACQUIRED CBCT, STRUCTURE SET AND SRO FILES ALL IN ONE SET; MOSAIQ WOULD PROCESS THEM ACCORDINGLY. CAUTION 7.2 (TECHNICAL PUBLICATION MOSAIQ 3.00 - 3.2.3.0 MOSAIQ SEQUENCE - VARIAN TRUEBEAM REFERENCE MANUAL): YOU MUST CLICK SAVE MATCH AFTER EACH MATCH BEFORE YOU CLICK APPLY. THIS MAKES SURE THAT SRO VALUES ARE SENT BACK AND ASSOCIATED WITH CORRECT IMAGE SETS. IN THIS CASE DUE TO THE NON-RECOMMENDED WORKFLOW, MOSAIQ RECEIVED THE CBCT'S, STRUCTURE SETS AND SRO FILES OUT OF SYNC WHICH WOULD CAUSE THE DISPLAY OF THE CBCTS TO BE INCORRECT WITH THE OFFSETS INFORMATION IN THE 3D IMAGER REVIEW. THIS INCORRECT DISPLAY MAY CAUSE CONFUSION WHEN VIEWED BUT DOES NOT LEAD TO ANY MISTREATMENT SINCE THE CORRECT SHIFTS AND TREATMENTS WERE COMPLETED ON THE MACHINE. MOSAIQ DID NOT HAVE ANY MALFUNCTION AND WAS WORKING AS DESIGNED AND INTENDED. BASED ON AVAILABLE INFORMATION THERE WAS NO MISTREATMENT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CBCT (CONE BEAM COMPUTED TOMOGRAPHY) TIME STAMPS APPEAR TO BE SWITCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39015 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB VERSION 2.86.084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown