Recall Z-1104-2020— Dexcom Inc

Name: FDA recall Z-1104-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-19

Class II · Terminated

Class II FDA medical device recall by Dexcom Inc, initiated 2019-11-19, terminated 2023-08-22. It names one FDA 510(k) clearance: K191450. 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: 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..

Recalling firm: Dexcom Inc
Classification: Class II
Status: Terminated
Initiated: 2019-11-19
Terminated: 2023-08-22
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K191450 — Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring SystemDexcom, Inc.·cleared 2019-06-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.