Dexcom G6 CGM App iOS Software Recall for Low Alarm Defect
Dexcom Inc is recalling the Dexcom G6 CGM App for iOS due to a software defect that may prevent low blood glucose alarms from triggering correctly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could prevent critical low blood glucose alarms from triggering, posing a risk of harm to users, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Dexcom Inc is recalling the Dexcom G6 CGM App for iOS, software number SW11677, versions 1.4.0 through 1.4.4. The recall involves 237,888 registered users in the United States and several international markets, including Austria, Belgium, Canada, and others.
The recall was initiated because the application's low alarm feature may not properly alert users when the Alert Schedule feature is enabled more than 30 days after the initial installation of the app. This defect could result in users not receiving critical low blood glucose warnings.
Consumers using the affected software versions should update their application to the corrected version 1.4.4 or later to ensure the low alarm feature functions as intended.
The recalled product
- 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
- Manufacturer
- Dexcom Inc
- Affected units
- 237,888
Distribution
Distribution scope not specified by the agency.
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