BEUDAMED
    FDA Enforcement Class II Ongoing

    MOSAIQ Oncology Information System

    Recall: Z-2591-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2591-2021
    Event ID
    88599
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 6, 2021
    Initiation Date
    September 2, 2021
    Classification Date
    September 29, 2021
    Address
    100 Mathilda Pl, 5th Floor, Sunnyvale, CA, 94086-6076, United States

    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.

    Code Info

    MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)

    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