Recall Z-2450-2025 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom, Inc.
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System
| Date | Sep 4, 2025 (initiated Jul 24, 2025) |
| Status | Open, Classified |
| Reason | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen |
| Root cause | Software design |
| Action | On 07/24/2025, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION" via in-app messaging informing users that a software bug was identified with users using the following app version: -Dexcom ONE+ iOS/Android App version 1.4 and all earlier versions, -Dexcom G7 iOS/G7 Watch iOS/Android App versions 2.8 and earlier The software bug can cause an issue where, when a transmitter error occurs, the app terminates the sensor session and prompts the user to "start a new sensor" without providing a "sensor failed" alert. Customer are instructed that an upgrade from app version version the |
| Quantity | 39309 |
| Distribution | SW12299 G7 Android CGM App Worldwide Distribution - US Nationwide and the countries of Andorra, United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.