BEUDAMED
    FDA Enforcement Class II Ongoing

    MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

    Recall: Z-1078-2026 · Reported January 21, 2026

    Enforcement

    Recall Number
    Z-1078-2026
    Event ID
    98116
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    January 21, 2026
    Initiation Date
    December 10, 2025
    Classification Date
    January 13, 2026
    Address
    400 Perimeter Center Ter NE Ste 50, Atlanta, GA, 30346-1227, United States

    Description

    MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

    Reason

    Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice

    Code Info

    MOSAIQ v 3.10.200, and 3.1.1.0 up to and including v 3.2.3.1 with Particle Base. Software Versions: 3.10.200, 3.1.1.0, 3.1.2.0, 3.1.3.0, 3.1.3.1, 3.1.3.2, 3.1.3.3, 3.1.3.4, 3.2.0.0, 3.2.1.0, 3.2.1.1, 3.2.1.2, 3.2.1.3, 3.2.1.4, 3.2.2.0, 3.2.2.1, 3.2.3.0, 3.2.3.1 UDI-DI: 07340201500026, 07340201500071

    Distribution

    US Nationwide distribution in the state of TX.

    Quantity

    1