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Recall Observatory FDA recall evidence

Device product

Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System

Z-0318-2026

August 28, 2025

Class I

Product summary

Firm
Dexcom, Inc.
Event
Event 97607
Status
Ongoing
Classification
Class I
Quantity
333
Official record key
device-enforcement:Z-0318-2026

Official wording

Reason: A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).

Code information: Lot Code: UDI: SW11678 - 00386270000811

Distribution pattern: This product was distributed throughout the US. G6 Android US v1.15.0 SW11678 G6 and G6 Pro Android app release has been halted <1% rollout after this issue was identified. Please see the attached consignee data for additional details.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software defect