Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
Check against the official notice below — it lists the full affected range.
Dexcom Inc. is recalling the Dexcom G6 CGM App for iOS (Software Version 1.4.0 through 1.4.4) because the low alarm feature does not properly alert users when the Alert Schedule feature is enabled more than 30 days after the app is installed. This means users who set up their alert schedules after that 30-day window may not receive notifications when their glucose levels drop too low. The issue affects approximately 237,888 registered users in the United States and multiple countries including Canada, the United Kingdom, Germany, and others.
The record does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application.
Reason for recall: It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application. Distribution: US Nation-wide OUS: Austria; Belgium; Canada; Czechia; Denmark; Finland; Germany; Great Britain; Hong Kong; Ireland; Italy; Luxembourg; Netherlands; Norway; South Africa; Spain; Sweden, and Switzerland. Quantity: 237888 users registered. Lot/code info: Software Number: SW11677 Software Version: 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.