Recall Z-1202-2025 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom, Inc.
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
| Date | Feb 20, 2025 (initiated Jan 27, 2025) |
| Status | Open, Classified |
| Reason | 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 in the |
| Root cause | Software design |
| Action | On January 27, 2025, Dexcom issued a "Urgent: Medical Device Correction to affected consignees via E-Mail. Dexcom asked consignees to take the following actions: If available, use the G6 App as primary display device to receive glucose readings and alerts. The G6 transmitter allows simultaneous communication with an iOS or Android device as well as a receiver (see letter for additional details). If using an affected G6 Receiver, check CGM glucose values and glucose trend regularly as CGM glucose values and glucose trend graph information continue to be displayed If you believe you may be |
| Distribution | Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA and the countries of Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Ireland, Japan, Netherlands, Slovenia, United Kingdom, Australia, Czech Republic, Denmark, Finland, France, Hong Kon |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System Dexcom, Inc., Jan 11, 2023 |