FDA-Device2026-01-28Class IIPROCESSING DEFECT
Edan X8, X10, X12 patient monitors recalled for cybersecurity vulnerabilities
What this means
Edan Diagnostics received an FDA warning letter about potential cybersecurity issues affecting certain X-series patient monitors (models X8, X10, and X12) used in hospitals and clinics. These devices continuously monitor patient vital signs, and security vulnerabilities could potentially allow unauthorized access.
- If your facility uses an Edan X8, X10, or X12 patient monitor, check the serial number against the FDA recall list
- Contact Edan Diagnostics or your equipment supplier for guidance on security updates or device replacement
- Do not discontinue use of the monitor without consulting your medical equipment team or Edan directly
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
3824
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1148-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.