Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001
FDA device recall Z-1204-2025 · posted 2025-02-20 · Open, Classified
Recall details
- Recalling firm
- Dexcom, Inc.
- Reason for recall
- 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.
- Action taken
- On January 27, 2025, Dexcom issued a "Urgent: Medical Device Correction to affected consignees via E-Mail. Dexcom asked consignees to take the following actions: If available, use the G6 App as primary display device to receive glucose readings and alerts. The G6 transmitter allows simultaneous communication with an iOS or Android device as well as a receiver (see letter for additional details). If using an affected G6 Receiver, check CGM glucose values and glucose trend regularly as CGM glucose values and glucose trend graph information continue to be displayed If you believe you may be experiencing the missed or delayed alarm/alerts issue, the issue can be corrected by shutting down the receiver and then turning it back on. Please navigate to the following webpage: https://www.dexcom.com/g6-receiver-update Please read the information provided on the webpage and any recommended actions regarding a software update for your receiver to permanently resolve this issue.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- QBJ
- 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, N
- Date initiated
- 2025-01-27
- Date posted
- 2025-02-20
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Dexcom G6 Continuous Glucose Monitoring (CGM) System (K223931) | Dexcom, Inc. | 2023-01-11 |