# FDA recall Z-1104-2020

> **Dexcom Inc** · Class II · device recall initiated 2019-11-19.

## 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

## 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.

## Key facts

- **Recall number:** Z-1104-2020
- **Recalling firm:** Dexcom Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-19
- **Report date:** 2020-02-19
- **Termination date:** 2023-08-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1104-2020

## Citation

> AI Analytics. FDA recall Z-1104-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-1104-2020. Source: US FDA. Licensed CC0.

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