FDA-Device2026-01-28Class IIPROCESSING DEFECT
Edan iT20 telemetry transmitter recalled for potential cybersecurity vulnerabilities
OTHERNationwide distribution
Check your Edan iT20 telemetry transmitter
The FDA identified potential cybersecurity issues with Edan's iT20 telemetry transmitter, a device used in hospitals to monitor patient heart rhythm and oxygen levels wirelessly. The company received an FDA notice asking it to address these vulnerabilities. No injuries have been reported.
- Check if your facility uses an Edan iT20 transmitter by comparing the model number and serial/lot number to the recall list
- Contact Edan Diagnostics or your equipment supplier for instructions on updates or replacements
- Do not discontinue patient monitoring; follow your facility's protocol for device management
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.
Sold states
Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
Affected count
1457
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1155-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief