Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black...
FDA Device Recall #Z-1336-2016 — Class I — February 23, 2016
Recall Summary
| Recall Number | Z-1336-2016 |
| Classification | Class I — Serious risk |
| Date Initiated | February 23, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Dexcom Inc |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 5,722 |
Product Description
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, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.
Reason for Recall
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Distribution Pattern
Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.
Lot / Code Information
Receiver Kit Number: STK-PU-001 Lot Number: 5176532 5176533 5176534 5176535 5176536 5188586 5189596 5190560 5191152 5191737 5191738 5192934 5193038 5194193 5194322 5195147 5195148 5195352 5195803 5195913 5196152 5197013 5197677 5198614 5200903 5200904 5200916 5201455 5201669 5202100 5202149 5202429 5202646 5202790 5202795 5202803 5202804 5202906 5203313 5203474 5203485 5203536 5204330 5204333 5205041 5206612 5206643 5208018 5208332 5208810 5210472
Other Recalls from Dexcom Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1562-2020 | Class II | Dexcom G6 Continuous Glucose Monitoring System ... | Feb 3, 2020 |
| Z-1560-2020 | Class II | Dexcom G4 PLATINUM Continuous Glucose Monitorin... | Feb 3, 2020 |
| Z-1561-2020 | Class II | Dexcom G5 Continuous Glucose Monitoring System ... | Feb 3, 2020 |
| Z-1104-2020 | Class II | Brand Name: Dexcom G6 CGM App for iOS Software... | Nov 19, 2019 |
| Z-0929-2020 | Class II | Dexcom Receiver, REF: MT22719, (Black, Pin, Bl... | Jul 12, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.