BEUDAMED
    FDA Enforcement Class II Terminated

    MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.

    Recall: Z-0447-2016 · Reported December 23, 2015

    Enforcement

    Recall Number
    Z-0447-2016
    Event ID
    72725
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 23, 2015
    Initiation Date
    November 24, 2015
    Classification Date
    December 17, 2015
    Termination Date
    September 15, 2021
    Address
    400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, 30346-1227, United States

    Description

    MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.

    Reason

    First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.

    Code Info

    Versions prior to 2.60.

    Distribution

    Nationwide Distribution -- AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, & Puerto Rico.

    Quantity

    211