FDA-Device2026-01-28Class IIPROCESSING DEFECT
Edan iM3 vital signs monitor recalled for cybersecurity vulnerabilities
What this means
The FDA identified potential cybersecurity issues with Edan's iM3 vital signs monitor, a device used in hospitals and clinics to measure blood pressure, oxygen levels, heart rate, and temperature. The company has been notified and is working to address these vulnerabilities.
- If your facility uses an Edan iM3 monitor, verify your device's serial number against the recall lot list
- Contact Edan Diagnostics or your equipment supplier for guidance on available security updates or patches
- Do not discontinue use of the device without consulting your IT or biomedical team
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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
11987
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1143-2026Want us to check the next one for you?
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