BEUDAMED
    FDA Recall Open, Classified

    Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system

    Recall: Z-1906-2025 · Initiated May 5, 2025

    Recall

    Recall Number
    Z-1906-2025
    Event Number
    96684
    Firm
    Dexcom, Inc.
    FEI Number
    3004753838
    Product Code
    QBJ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    May 5, 2025
    Posted
    June 4, 2025
    Address
    6340 Sequence Dr, San Diego, CA, 92121-4356

    Description

    Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system

    Reason

    A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.

    Action

    On May 05, 2025, Dexcom issued a "Urgent Warning" Recall notification to affected consignees via application update. Dexcom asked consignees to take the following actions: 1. Upgrading from app version 2.7 is mandatory and app version 2.7 is no longer available for use. 2. If you need assistance, contact Technical Support. Local Tech Support contact information is available at Dexcom.com Please note that US customers should utilize one of the following options for support. " Phone - 1-844-478-1600 " Call Back request Call Back Request Form " Web Form - https://dexcom.custhelp.com/app/webform " Live chat - https://dexcom.custhelp.com/app/chat/chat_avail If you have any questions, call 858-200-0200 or email: [email protected].

    Distribution

    Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: United Arab Emirates (AE), Austria (AT), Australia (AU), Belgium (BE), Bahrain (BH), Canada (CA), Switzerland (CH), Czech Republic (CZ), Germany (DE), Denmark (DK), Spain (ES), Finland (FI), France (FR), United Kingdom (GB), Hong Kong (HK), Ireland (IE), Israel (IL), Iceland (IS), Italy (IT), Jordan (JO), Korea, Repulic (KR), Kuwait (KW), Lebanon (LB), Lithuania (LT), Luxemburg (LU), Malta (MT), Netherlands (NL), Norway (NO), New Zealand (NZ), Oman (OM), Poland (PL), Portugal (PT), Qatar (QA), Saudi Arabia (SA), Sweden (SE), Slovenia (SI), Slovakia (SK), Turkey (TR) and South Africa (ZA).

    Quantity

    61,355 users