BEUDAMED
    FDA Recall Open, Classified

    MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)3.2.1.4 3.2.2.0 (01)07340201500071(10)3.2.2.0 3.2.2.1 (01)07340201500071(10)3.2.2.1 3.2.3.0 (01)07340201500071(10)3.2.3.0 MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

    Recall: Z-0503-2026 · Initiated September 17, 2025

    Recall

    Recall Number
    Z-0503-2026
    Event Number
    97562
    Firm
    ELEKTA SOLUTIONS AB
    FEI Number
    3015232217
    Product Code
    IYE
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 17, 2025
    Posted
    November 14, 2025
    Address
    Box 7593, Haga Plan 4, Stockholm Sweden

    Description

    MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)3.2.1.4 3.2.2.0 (01)07340201500071(10)3.2.2.0 3.2.2.1 (01)07340201500071(10)3.2.2.1 3.2.3.0 (01)07340201500071(10)3.2.3.0 MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

    Reason

    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.

    Action

    On 09/17/2025, the firm emailed an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" to customers informing them 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. Customers are instructed to: When appending cycles for care plans that contain additional medication orders with a wave schedule, review and adjust the appended care plan cycles to reflect the clinical intent. Alternatively, wave orders can be removed from the care plan folder. Additional information can be found in: Customers with v3.1.3 - section 3.4.1 - page 35-36 in doc E062133 / 01 MOSAIQ 3.1.3.0 Instructions for Use Customers with v3.2.1 - section 3.4.1 - page 35-36 in doc E065117 / 03 MOSAIQ 3.2.1.0 Instructions for Use Customers with v3.2.2 - section 3.4.1 - page 35-36 in doc E067652 / 04 MOSAIQ 3.2.2.0 Instructions for Use Customers with v3.2.3.0 - section 3.4.1 - page 35-36 in doc E071967 / 01 MOSAIQ 3.2.3.0 Instructions for Use For questions - contact Quality Assurance at +46 70-962-0862 or email [email protected]

    Distribution

    Worldwide - U.S. Nationwide distribution in the state of NM and the countries of Canada, Malta, and South Africa.

    Quantity

    4 systems that contain the affected software.