Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 24, 2025 |
| Reported | January 28, 2026 |
| Recalling firm | Edan Diagnostics |
| Country / region | United States CA |
Hazard
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Product description
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No
Affected products
- Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and
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