BEUDAMED
    FDA Enforcement Class II Ongoing

    Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.

    Recall: Z-1786-2019 · Reported June 26, 2019

    Enforcement

    Recall Number
    Z-1786-2019
    Event ID
    82828
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Monarch Medical Technologies
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 26, 2019
    Initiation Date
    May 3, 2019
    Classification Date
    June 15, 2019
    Address
    2137 South Blvd Ste 300, N/A, Charlotte, NC, 28203-5189, United States

    Description

    Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.

    Reason

    Insulin dosing calculations were erroneously high.

    Code Info

    Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10

    Distribution

    Nationwide and Dubai

    Quantity

    83 downloads