BEUDAMED
    FDA Enforcement Class II Terminated

    MOSAIQ, 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-1800-2014 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1800-2014
    Event ID
    68355
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2014
    Initiation Date
    May 23, 2014
    Classification Date
    June 16, 2014
    Termination Date
    July 16, 2021
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227, United States

    Description

    MOSAIQ, 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 using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse to a different area of the screen.

    Code Info

    N/A - Software versions 1.40 through 2.50, inclusive

    Distribution

    Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gabon, Germany, Ghana, Greece, Honduras, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sudan, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine and Venezuela.

    Quantity

    723