BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0447-2016 · Initiated November 24, 2015

    Recall

    Recall Number
    Z-0447-2016
    Event Number
    72725
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 24, 2015
    Terminated
    September 15, 2021
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    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.

    Action

    Elekta sent an Urgent Important Field Safety Notice 371-01-MSQ-004 to all affected customers on 11/24/2015. The notice informs users to the issue, the work around and the solution. The customers are instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta Office or Representative, as soon as possible but no longer than 30 days from receipt.

    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