EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intende...
FDA Device Recall #Z-1256-2020 — Class II — November 17, 2017
Recall Summary
| Recall Number | Z-1256-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 17, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Edan Diagnostics |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 7 units |
Product Description
EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)
Reason for Recall
Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.
Distribution Pattern
U.S. Nationwide distribution in the state of CA.
Lot / Code Information
Serial Numbers: 260638-M16400850001 260638-M17211500001 260638-M17211500002 260638-M17211500003 260638-M17211500004 261350-M17A03030001 261350-M17A03030002
Other Recalls from Edan Diagnostics
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1140-2026 | Class II | Brand Name: EDAN Product Name: Fetal Monitor ... | Oct 24, 2025 |
| Z-1151-2026 | Class II | Brand Name: EDAN Product Name: Central Monitor... | Oct 24, 2025 |
| Z-1155-2026 | Class II | Brand Name: EDAN Product Name: Telemetry Trans... | Oct 24, 2025 |
| Z-1149-2026 | Class II | Brand Name: EDAN Product Name: Patient Monitor... | Oct 24, 2025 |
| Z-1146-2026 | Class II | Brand Name: EDAN Product Name: Patient Monitor... | Oct 24, 2025 |
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.