BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 22872251 · Received August 22, 2025

    Report

    Report Number
    3015232217-2025-00052
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Report Date
    February 19, 2026
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    07340201500071
    PMA / PMN Number
    K223229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H4: MANUFACTURING DATE IS NOT ON THE LABEL, BUT IT IS KNOWN SO FIELD H4 HAS BEEN COMPLETED WITH THIS INFORMATION. H11: THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 0

    H6 UPDATED. H7 UPDATED. H11 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. WHEN APPENDING A CARE PLAN THAT CONTAINS ONE OR MORE WAVE MEDICATION ORDERS, THE OCCURRENCE AND FREQUENCY OF THE APPENDED ORDERS MAY NOT MATCH THE INTENDED SCHEDULE. IF THE CARE PLAN IS NOT APPENDED, IT MAY RESULT IN ONE OR MORE DOSES OF THE MEDICATION(S) NOT BEING ADMINISTERED. THE PROBLEM WAS DETECTED DURING INTERNAL TESTING. ELEKTA HAVE NOT RECEIVED ANY CUSTOMER REPORTS AND NO OCCURRENCES OF MISTREATMENT HAVE BEEN REPORTED. AN IMPORTANT FIELD SAFETY NOTIFICATION (371-01-MSQ-020) WAS SENT TO ALL AFFECTED CUSTOMERS FROM 5 SEPTEMBER 2025 (ELEKTA REFERENCE #: FCA-ESAB-0006). THIS ISSUE IS RESOLVED IN MOSAIQ 3.2.3.1 VIA A FIELD SAFETY MODIFICATION REPORTED TO THE REGULATORY AUTHORITY ON 7 JANUARY 2026 AND A PRODUCT BULLETIN (371-05-MSQ-090) WAS RELEASED TO AFFECTED CUSTOMERS ON 22/12/2025, CUSTOMERS WILL BE CONTACTED AND ARRANGEMENTS WILL BE MADE FOR THEIR DEVICES TO BE CORRECTED ACCORDINGLY.

    Description of Event or Problem · 0

    INTERNAL TESTING REVEALED THAT WAVED ORDER SETS ADDED TO REGIMEN FOLDER OF CARE PLAN THAT DO NOT FALL ON CARE PLAN CYCLE DAYS ARE NOT APPENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439896 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB VERSION 3.2.3.0 07340201500071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown