Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1203-2025 — Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001

U.S. FDA — Device Enforcement · United States · 2025-01-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1203-2025
Date of alert
2025-01-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Dexcom, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00386270000590
Reported risk: 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 missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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