FDA-Device2026-01-28Class IIPROCESSING DEFECT
Edan M3B Vital Signs Monitor recalled for cybersecurity vulnerabilities
What this means
The FDA identified potential cybersecurity issues with Edan's M3B Vital Signs Monitor, a hospital device that tracks oxygen levels, heart rate, and CO2. Certain serial numbers manufactured between 2015 and 2024 may be affected. No patient injuries have been reported.
- Check if your M3B monitor's serial number matches the affected list provided by Edan or the FDA
- Contact Edan Diagnostics or your hospital's medical device team for instructions on security updates or replacement
- Do not discontinue use of the device without a replacement plan in place
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
354
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1152-2026Want us to check the next one for you?
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