BEUDAMED
    FDA Recall Terminated

    MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery

    Recall: Z-0686-2019 · Initiated December 4, 2018

    Recall

    Recall Number
    Z-0686-2019
    Event Number
    81705
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 4, 2018
    Terminated
    February 23, 2026
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    Description

    MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery

    Reason

    If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.

    Action

    Elekta notified customers on about 12/04/2018 via letter titled, "Urgent Important Field Safety Notification." The letter contains recommended user action and that appropriate personnel working with the device should be advised on the content of the letter and the letter should be placed in an area accessible to all users. The letter stated that the issue will be resolved in Service Packs to MOSAIQ Releases 2.64, 2.65 and 2.70. Customers will be informed when the fix is available through a Product Bulletin. An acknowledgement Form was sent as part of the letter to be completed and returned no later than 30 days. The firm can be contacted at 408-830-8000 or 855-693-5358.

    Distribution

    Distributed in the United States and outside of the Unites States: Algeria; Antigua and Barbuda; Argentina; Australia; Belgium; Botswana; Brazil; Canada; China; Colombia; Denmark; France; Germany; India; Indonesia; Iran; Ireland; Israel; Italy; Japan; Latvia; Lebanon; Malaysia; Mexico; Morocco; Myanmar; Netherlands; New Zealand; Norway; Peru; Philippines; Poland; Portugal; Russian Federation; Rwanda; Saudi Arabia; Senegal; Singapore; Slovenia; South Africa; Spain; Sweden; Switzerland; Taiwan; Thailand; Turkey; United Kingdom; Viet Nam

    Quantity

    551 units