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FDA · FDA event 97607 · Posted Oct 30, 2025
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).
The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.
| Model | Description | Lot / serial range | Manufactured | Status |
|---|---|---|---|---|
| Z-0318-2026 · SW11678 · version 1.15.0 | Dexcom G6 and G6 Pro Android US CGM App | Lot Code: UDI: SW11678 - 00386270000811 | Not provided in the normalized record | Ongoing |
Aug 28, 2025
Recall initiated
Date recorded by the FDA.
Oct 30, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.