FDA-Device2026-01-28Class IIPROCESSING DEFECT
Edan iX10, iX12, iX15 patient monitors recalled for cybersecurity vulnerabilities
What this means
The FDA identified potential cybersecurity issues with certain Edan iX series patient monitors (models iX10, iX12, iX15). These devices are used in hospitals and clinics to continuously monitor patients' vital signs. The affected units have specific serial numbers and manufacturing dates.
- Find your monitor's serial number on the device or documentation
- Check if it matches one of the affected lots listed in the FDA notice
- Contact your facility's biomedical or IT department if you have an affected unit
- Visit the FDA website for the complete list of affected serial numbers
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
379
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 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 abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1149-2026Want 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.