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FDA-Device2026-01-28Class IIPROCESSING DEFECT

Edan MFM-CNS and MFM-CNS Lite fetal monitoring software recalled for cybersecurity vulnerabilities

Edan Diagnostics
OTHERNationwide distribution

Check your Edan fetal monitoring system

Edan Diagnostics' MFM-CNS and MFM-CNS Lite clinical software systems for fetal and maternal monitoring have potential cybersecurity vulnerabilities. The FDA identified these issues and requested action from the manufacturer. No patient harm has been reported.

  • Identify if your facility uses an Edan MFM-CNS or MFM-CNS Lite system
  • Check the serial number against the affected lot list
  • Contact Edan Diagnostics or your facility's biomedical team for firmware updates or guidance
  • Do not delay clinical care while addressing this issue
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
395
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1151-2026

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