BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1078-2026 · Initiated December 10, 2025

    Recall

    Recall Number
    Z-1078-2026
    Event Number
    98116
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    December 10, 2025
    Posted
    January 13, 2026
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    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

    Action

    On 12/10/2025 correction notices were emailed to consignees who were asked to do the following: Radiation therapists must always check the meterset values displayed on the MOSAIQ console with the value displayed on the treatment unit console. If a mismatch occurs, follow Caution 9.6 in the MOSAIQ Instructions for Use. Complete and return the acknowledgement form. Firm is working on the correction and will release a Field Safety Modification with the details as soon as possible. Elekta Regional Contact Details: Region America: [email protected] Tel: +1 855 6935358 https://www.elekta.com Region Asia Pacific: [email protected] Tel: + 852 2891 2208 https://www.elekta.com Japan [email protected] Tel: + 81 3 6722 3800 Fax: +81 3 6436 4231 https://www.elekta.com Region China: [email protected] Tel : + 86 10 8012 5012 https://www.elekta.com Region Europe: [email protected] Tel : + 46 8 587 254 00 https://www.elekta.com Region Turkey, India & Middle East [email protected] Turkey Tel: +90 216 444 6374 India Tel: +1-800-103-7454 Middle East Tel: +00 800 4000 5000 https://www.elekta.com

    Distribution

    US Nationwide distribution in the state of TX.

    Quantity

    1