Edan recalls iT20 Telemetry Transmitters due to potential cybersecurity issues. Affected units have serial numbers listed in the record. Consumers should check their device and contact Edan for details.
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.
Edan is recalling its iT20 Telemetry Transmitters after receiving an FDA alert about potential cybersecurity issues. This could allow unauthorized access to health data collected by the device. The recall does not specify a risk of injury but addresses a security vulnerability.
The device has a cybersecurity vulnerability that could potentially allow unauthorized access to health data collected by the device. This is a security risk rather than a physical hazard, as the FDA alert does not mention injury or physical harm.
Users of the Edan iT20 Telemetry Transmitter who have the listed serial numbers are affected. This includes medical device users who collect physiological data via ECG and SpO2 sensors.
Check if your Edan iT20 Telemetry Transmitter has a serial number listed in the provided record. The device collects physiological data through ECG and SpO2 sensors and sends it via Wi-Fi to a medical management system.
Look for the serial number on your Edan iT20 Telemetry Transmitter. If it matches any of the listed serial numbers in the recall record, it is affected.
The recall addresses a cybersecurity issue, not a risk of injury. The FDA alert does not mention physical harm.
Compare your device's serial number to the list of affected serial numbers provided in the recall record.
The recall does not specify a remedy. Contact Edan Diagnostics directly for further instructions.
We’ve drafted a message you can send Edan to request your refund or repair — edit it as you like.
Subject: Recall Z-1155-2026 — Edan Edan Hello, I own a Edan that is covered by recall Z-1155-2026 from Edan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
