BEUDAMED
    FDA Enforcement Class II Ongoing

    MOSAIQ Oncology Information System

    Recall: Z-2293-2016 · Reported August 3, 2016

    Enforcement

    Recall Number
    Z-2293-2016
    Event ID
    74668
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2016
    Initiation Date
    July 15, 2016
    Classification Date
    July 27, 2016
    Address
    400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, 30346-1227, United States

    Description

    MOSAIQ Oncology Information System

    Reason

    It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.

    Code Info

    Versions 2.50.05 and higher

    Distribution

    Worldwide distribution. US nationwide, Antigua and Barbuda, Australia, Austria, Bahamas, Bahrain, Canada, Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and United Kingdom

    Quantity

    383