BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System

    Recall: Z-0318-2026 · Initiated August 28, 2025

    Recall

    Recall Number
    Z-0318-2026
    Event Number
    97607
    Firm
    Dexcom, Inc.
    FEI Number
    3004753838
    Product Code
    QBJ
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    August 28, 2025
    Posted
    October 30, 2025
    Address
    6340 Sequence Dr, San Diego, CA, 92121-4356

    Description

    Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System

    Reason

    A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).

    Action

    On 09/18/2025, the firm sent via in-app and email an "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION" communication informing customer that a bug has been identified within the G6 Android app version 1.15.0 that can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, or alerts. Customers are instructed to: Upgrading from app version 1.15.0 is mandatory and they will not be able to use app version 1.15.0 after October 6th, 2025. Update your app now to continue using the app: 1. Open the App Store and search for the Dexcom G6 app. 2. Install the latest Dexcom G6 app version. 3. Open the Dexcom G6 app. For questions or further assistance - contact Technical Support at 1-844-478-1600. Technical Support is available 24 hours a day/7 days a week

    Distribution

    This product was distributed throughout the US. G6 Android US v1.15.0 SW11678 G6 and G6 Pro Android app release has been halted <1% rollout after this issue was identified. Please see the attached consignee data for additional details.

    Quantity

    333