FDA (Devices) recall action 96091
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result i…
The agency’s own wording, quoted from the enforcement report.
The Dexcom G6 receiver may rarely fail to deliver or delay glucose alarms due to a software error, potentially missing dangerous blood sugar events. No illnesses have been reported.
Under rare conditions, the Dexcom G6 receiver may fail to send high or low glucose alarms due to a software error, potentially delaying detection of dangerous blood sugar levels.
Dexcom G6 continuous glucose monitors may fail to deliver high or low blood sugar alarms due to a software error, potentially delaying detection of dangerous glucose levels. Alarms will be delayed and skip in sequence until the device is reset.