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 for diabetes patients.
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 patients with diabetes, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Dexcom Inc is recalling 5,722 units of the Dexcom G4 PLATINUM (Professional) Receiver, part number MT20649. The device is intended to detect trends and track glucose patterns in persons with diabetes. The recall covers specific lot numbers listed in the agency documentation.
The recall was initiated 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 critical glucose readings.
The affected products were distributed worldwide, including the United States, Canada, and numerous countries in Europe, Asia, and the Middle East. Consumers with these specific receiver units should contact Dexcom Inc for instructions on how to proceed.
The recalled product
- Product
- Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT2064
- Manufacturer
- Dexcom Inc
- Affected units
- 5,722
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 →Related recalls
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