Reported Feb 19, 2020 · Terminated
Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version…
Dexcom Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dexcom Inc · 6340 Sequence Dr · San Diego, CA · 92121-4356
Is this the product you have?
- Brand NameDexcom
- G6 CGM App for iOS Software NumberSW11677
- Software VersionVersion 1.4.0 up to corrected Version 1.4.4
- GUDID Registered GTIN00386270000804
- Lot codes and dates
- Software NumberSW11677
- Software Version1.4.0 up to corrected Version 1.4.4
- GUDID Registered GTIN00386270000804
- Amount recalled
- 237888 users registered.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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