BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 23551981 · Received November 14, 2025

    Report

    Report Number
    3015232217-2025-00071
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 22, 2025
    Report Date
    March 20, 2026
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    07340201500071
    PMA / PMN Number
    K223229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    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. THE CUSTOMER REPORTED THAT A PARTIAL THAT IS RECORDED AS VERIFIED TREATMENT FOLLOWED BY AN ADDITIONAL PARTIAL THAT IS RECORDED MANUALLY LEADS TO INCORRECT METERSET BEING SENT TO MACHINE. ON (B)(6) 2025, FIELD 1 WAS PARTIALLY TREATED WITH 200,533.3 MP RECORDED. THE USER THEN MANUALLY ENTERED AN ADDITIONAL PARTIAL DOSE OF 52,444 MP, BRINGING THE COMBINED TOTAL TO 252,977.3 MP OUT OF THE PRESCRIBED 333,922.5 MP. WHEN THE USER ATTEMPTED TO DELIVER THE REMAINING 80,945.2 MP, THE SYSTEM INCORRECTLY IGNORED THE MANUAL ENTRY AND CALCULATED THE REMAINDER BASED ONLY ON THE INITIAL VERIFIED DOSE, SENDING 133,389.2 MP FOR DELIVERY. CONSEQUENTLY, DURING CONTINUATION OF TREATMENT TO FIELD 1, THE PATIENT RECEIVED 133,396.9 MP INSTEAD OF 80,945.2 MP, RESULTING IN AN OVERDOSE OF 52,451.7 MP. IN THIS CASE, THE PATIENT RECEIVED AN EXCESS DOSE OF 52,451 MP DURING A SINGLE TREATMENT DAY. THE PRESCRIBED DOSE PER DAY WAS 333,922.5 MP, WITH A TOTAL OF FOUR FRACTIONS PLANNED. THEREFORE, THE OVERDOSE REPRESENTS APPROXIMATELY 16% FOR THAT DAY AND 3.9% ACROSS THE ENTIRE TREATMENT COURSE. ELEKTA PHYSICS HAVE ASSESSED THIS AS A NON-SERIOUS RADIATION OVERDOSE. AN IMPORTANT FIELD SAFETY NOTIFICATION (371-01-MSQ-021) WAS SENT TO ALL AFFECTED CUSTOMERS FROM 9 DECEMBER 2025 (ELEKTA REFERENCE #: (B)(4)). THE SOFTWARE CONTAINING THE CORRECTION WILL BE RELEASED TO THE FIELD VIA IMPORTANT FIELD SAFETY MODIFICATION. AFFECTED CUSTOMERS WILL BE NOTIFIED BY PRODUCT BULLETIN OF THE RELEASE AND A FIELD SERVICE ENGINEER WILL CONTACT EACH CUSTOMER AND ARRANGEMENTS WILL BE MADE FOR THEIR DEVICES TO BE CORRECTED ACCORDINGLY.

    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

    G1 UPDATED. H11 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE ISSUE WAS DETERMINED TO BE A DEFECT IN THE PRODUCT. THE CUSTOMER REPORTED THAT A PARTIAL THAT IS RECORDED AS VERIFIED TREATMENT FOLLOWED BY AN ADDITIONAL PARTIAL THAT IS RECORDED MANUALLY LEADS TO INCORRECT METERSET BEING SENT TO MACHINE. ON (B)(6) 2025, FIELD 1 WAS PARTIALLY TREATED WITH 200,533.3 MP RECORDED. THE USER THEN MANUALLY ENTERED AN ADDITIONAL PARTIAL DOSE OF 52,444 MP, BRINGING THE COMBINED TOTAL TO 252,977.3 MP OUT OF THE PRESCRIBED 333,922.5 MP. WHEN THE USER ATTEMPTED TO DELIVER THE REMAINING 80,945.2 MP, THE SYSTEM INCORRECTLY IGNORED THE MANUAL ENTRY AND CALCULATED THE REMAINDER BASED ONLY ON THE INITIAL VERIFIED DOSE, SENDING 133,389.2 MP FOR DELIVERY. CONSEQUENTLY, DURING CONTINUATION OF TREATMENT TO FIELD 1, THE PATIENT RECEIVED 133,396.9 MP INSTEAD OF 80,945.2 MP, RESULTING IN AN OVERDOSE OF 52,451.7 MP. IN THIS CASE, THE PATIENT RECEIVED AN EXCESS DOSE OF 52,451 MP DURING A SINGLE TREATMENT DAY. THE PRESCRIBED DOSE PER DAY WAS 333,922.5 MP, WITH A TOTAL OF FOUR FRACTIONS PLANNED. THEREFORE, THE OVERDOSE REPRESENTS APPROXIMATELY 16% FOR THAT DAY AND 3.9% ACROSS THE ENTIRE TREATMENT COURSE. ELEKTA PHYSICS HAVE ASSESSED THIS AS A NON-SERIOUS RADIATION OVERDOSE. AN IMPORTANT FIELD SAFETY NOTIFICATION (371-01-MSQ-021) WAS SENT TO ALL AFFECTED CUSTOMERS FROM 9 DECEMBER 2025 (ELEKTA REFERENCE #: (B)(4)). THE CORRECTION FOR THIS ISSUE HAS BEEN RELEASED TO THE FIELD, AND CUSTOMERS HAVE BEEN NOTIFIED THROUGH PRODUCT BULLETIN (ELEKTA REF: 371-05-MSQ-093) ON 04/03/2026. CUSTOMERS WILL BE CONTACTED BY THEIR LOCAL ELEKTA REPRESENTATIVE TO SCHEDULE THE IMPLEMENTATION OF THE SOFTWARE UPDATE. THE PROBLEM IS RESOLVED IN MOSAIQ® RELEASE 3.2.3.2.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PARTIAL THAT IS RECORDED AS VERIFIED TREATMENT FOLLOWED BY AN ADDITIONAL PARTIAL THAT IS RECORDED MANUALLY LEADS TO INCORRECT METERSET BEING SENT TO MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259711 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB VERSION 3.2.3.0 07340201500071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown