BEUDAMED
    FDA Recall Open, Classified

    MOSAIQ Oncology Information System

    Recall: Z-2591-2021 · Initiated September 2, 2021

    Recall

    Recall Number
    Z-2591-2021
    Event Number
    88599
    Firm
    Elekta, Inc.
    FEI Number
    1000123805
    Product Code
    IYE
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 2, 2021
    Address
    100 Mathilda Pl, Floor 5th, Sunnyvale, CA, 94086-6076

    Description

    MOSAIQ Oncology Information System

    Reason

    A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.

    Action

    The recalling firm issued an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" dated August 2021 via email to its consignees on 9/2/2021. Recommendations were made to the user until a fix is available.

    Distribution

    Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA. There was no military/government distribution. Foreign distribution was made to Australia, Canada, and the United Kingdom.

    Quantity

    31