FDA Medical Device Recalls (openFDA)
Dexcom Inc: 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
- Recall number
- Z-1104-2020
- Recalling firm
- Dexcom Inc
- 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
- Status
- Terminated
- Initiated
- 2019-11-19
- Posted
- not on file
- Terminated
- 2023-08-22
- Reason
- 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.
- Root 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
- 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.
- Lot, serial or model codes
- Software Number: SW11677 Software Version: 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
- 510(k) numbers
- ["K191450"]
- PMA numbers
- not on file
- Product code
- QBJ
- Firm FEI
- 3004753838
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28