BEUDAMED
    FDA Enforcement Class II Ongoing

    Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001

    Recall: Z-1202-2025 · Reported February 26, 2025

    Enforcement

    Recall Number
    Z-1202-2025
    Event ID
    96091
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Dexcom, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    February 26, 2025
    Initiation Date
    January 27, 2025
    Classification Date
    February 20, 2025
    Address
    6340 Sequence Dr, N/A, San Diego, CA, 92121-4356, United States

    Description

    Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001

    Reason

    Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.

    Code Info

    All Serial Numbers/UDI: 00386270000583

    Distribution

    Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA and the countries of Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Ireland, Japan, Netherlands, Slovenia, United Kingdom, Australia, Czech Republic, Denmark, Finland, France, Hong Kong, Israel, Italy, Korea, Kuwait, New Zealand, Norway, Oman, Poland, Qatar, Saudi Arabia, Singapore, Slovakia, South Africa, Sweden, Turkey, United Arab Emirates.

    Quantity

    N/A