[pending] Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Descripti
Pending LLM rewrite. Source: FDA_DEVICE Z-1155-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- 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 para
- Manufacturer
- Edan Diagnostics
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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