BEUDAMED
    FDA Recall Open, Classified

    MOSAIQ Oncology Information System

    Recall: Z-2293-2016 · Initiated July 15, 2016

    Recall

    Recall Number
    Z-2293-2016
    Event Number
    74668
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    July 15, 2016
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    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.

    Action

    Elekta sent Important Field Safety Notice 371-03-MSQ-001 to all customers on 7/15/2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. The letter also included a response form which is to be returned to Elekta.

    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