BEUDAMED
    FDA Enforcement Class II Ongoing

    MOSAIQ Oncology Information System

    Recall: Z-1162-2025 · Reported February 19, 2025

    Enforcement

    Recall Number
    Z-1162-2025
    Event ID
    96153
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2025
    Initiation Date
    January 15, 2025
    Classification Date
    February 11, 2025
    Address
    400 Perimeter Center Ter NE Ste 50, Atlanta, GA, 30346-1227, United States

    Description

    MOSAIQ Oncology Information System

    Reason

    Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.

    Code Info

    Software versions /UDI: 3.1.2.0 (01)07340201500026 3.1.3.0 (01)07340201500026; 3.1.3.1 (01)07340201500026; 3.1.3.2 (01)07340201500026; 3.1.3.3 (01)07340201500026; 3.1.3.4 (01)07340201500026; 3.2.1.0 (01)07340201500071; 3.2.1.1 (01)07340201500071; 3.2.1.2 (01)07340201500071; 3.2.1.3 (01)07340201500071; 3.2.1.4 (01)07340201500071

    Distribution

    US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina Brazil Canada France Germany Hong Kong Italy Japan Korea, Republic of Malta Netherlands Panama South Africa Spain Taiwan Thailand Turkey Venezuela

    Quantity

    64 units