BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated May 3, 2019

    Recall

    Recall Number
    Z-1786-2019
    Event Number
    82828
    Firm
    Monarch Medical Technologies
    FEI Number
    3009864844
    Product Code
    NDC
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    May 3, 2019
    Address
    2137 South Blvd, Ste 300, Charlotte, NC, 28203-5189

    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.

    Action

    The firm notified the consignees by email beginning on 05/03/2019. The notice alerted the consignee of the problem and provided an educational brief and a tip card to provide to the staff to remind them to always use clinical judgement in following EndoTool IV dose recommendations.

    Distribution

    Nationwide and Dubai

    Quantity

    83 downloads