The Recall Desk
HighFDA (Devices)·Z-1334-2016·Announced 2016-04-20

Dexcom G4 Platinum Receiver Recall for Missing Audible Alarms

Dexcom Inc is recalling G4 PLATINUM Receivers because they may fail to provide intended audible alarms or alerts to users.

What this means for you

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 where a failure to provide audible alarms poses a risk of harm to users with diabetes, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Dexcom Inc is recalling the Dexcom G4 PLATINUM Receiver, which is intended to detect trends and track glucose patterns in persons with diabetes. The recall involves 131,768 units distributed worldwide, including the United States, Canada, and numerous other countries.

The recall is being issued because customers may not receive an intended audible alarm or alert if they are relying on hearing the alarm or alert. This defect could prevent users from being notified of glucose trends or patterns as intended.

Consumers with affected receivers should check their device against the specific part numbers and lot numbers listed in the official recall notice. Users should contact Dexcom Inc for instructions on how to resolve the issue.

The recalled product

Product
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
Manufacturer
Dexcom Inc
Affected units
131,768

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Dexcom Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →