Class 2 Device Recall Dexcom G6 CGM App for iOS

• Date Initiated by Firm: November 19, 2019
• Create Date: March 02, 2020
• Recall Status: Terminated on August 22, 2023
• Recall Number: Z-1104-2020
• Recall Event ID: 84436
• 510(K)Number: K191450
• Product Classification: Integrated Continuous Glucose Monitoring system, factory calibrated - Product Code QBJ
• Product: 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
• Code Information: Software Number: SW11677 Software Version: 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
• Recalling Firm/ Manufacturer: Dexcom Inc; 6340 Sequence Dr; San Diego CA 92121-4356
• For Additional Information Contact: Anita Rees; 858-875-9463
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: An updated G6 iOS CGM App was placed in the Apple App Store (SW11677 version 1.4.4) with messaging pushed to all US users on November 19, 2019. The messaging repeats to the user on a daily basis until the user updates (or is alternatively blocked from use of the app if they ignore the messaging and do not update). Messaging will be delivered directly to the end user through the following App Compatibility Messaging via the Apple App Store (see Compatibility Message and time-frame below): Duration: Day 1-3 Date Range: Nov 19-21 App Compatibility Message: Warning - Please update your Dexcom G6 iOS App from the Apple App Store. Failure to update your App may cause your alarms and alerts to not work as intended. Without alarms/alerts, you might miss a severe low or high glucose event. Contact technical support if you require assistance. Duration: Day 4-17 Date Range: Nov 22 - Dec 5 App Compatibility Message: Warning - This version of the Dexcom G6 iOS App will no longer be available for use as of December 6. Update the Dexcom G6 iOS App now from the Apple App Store to continue use of the Dexcom G6 iOS App. Contact technical support if you require assistance. Duration: Day 18 Date Range: Dec 6 App Compatibility Message: Warning - This version of the Dexcom G6 iOS App is no longer available for use. Update the Dexcom G6 iOS App now from the Apple App Store to continue use of the Dexcom G6 iOS App. Contact technical support if you require assistance. For impacted users, they will receive the Alert Settings Reset notification once the app update is complete and the app is launched or the app receives a communication from the Transmitter. The user must then reset any alarm/alert customizations made (or leave at factory default settings). For users currently not impacted, they will not receive the Alert Settings Reset notification. The updated version of the app corrects the problem for those impacted and prevents the problem from occurring for
• Quantity in Commerce: 237888 users registered.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = QBJ