Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) syste
FDA device recall Z-1906-2025 · posted 2025-06-04 · Open, Classified
Recall details
- Recalling firm
- Dexcom, Inc.
- Reason for recall
- 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 taken
- 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: Charles.boykin@dexcom.com.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- QBJ
- Quantity affected
- 61,355 users
- 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 Rep
- Date initiated
- 2025-05-05
- Date posted
- 2025-06-04
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Dexcom G7 Continuous Glucose Monitoring (CGM) System (K231081) | Dexcom, Inc. | 2023-05-15 |