BEUDAMED
    FDA Enforcement Class II Terminated

    Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804

    Recall: Z-1104-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1104-2020
    Event ID
    84436
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dexcom Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    February 19, 2020
    Initiation Date
    November 19, 2019
    Classification Date
    February 7, 2020
    Termination Date
    August 22, 2023
    Address
    6340 Sequence Dr, San Diego, CA, 92121-4356, United States

    Description

    Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804

    Reason

    It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application.

    Code Info

    Software Number: SW11677 Software Version: 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804

    Distribution

    US Nation-wide OUS: Austria; Belgium; Canada; Czechia; Denmark; Finland; Germany; Great Britain; Hong Kong; Ireland; Italy; Luxembourg; Netherlands; Norway; South Africa; Spain; Sweden, and Switzerland.

    Quantity

    237888 users registered.