Z-1104-2020 Class II Terminated
FDA device recall Z-1104-2020 was initiated by Dexcom Inc on November 19, 2019 and is designated Class II. 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 i… The recall status is terminated (terminated August 22, 2023). Affected quantity: 237888 users registered..
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- November 19, 2019
- Termination Date
- August 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 237888 users registered.
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.
Distribution Pattern
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.
Code Information
Software Number: SW11677 Software Version: 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804