FDA-Device2026-01-28Class IIPROCESSING DEFECT
Edan MFM-CMS central monitoring system recalled for cybersecurity vulnerabilities
OTHERNationwide distribution
Check Edan MFM-CMS central monitoring system
Edan Diagnostics' MFM-CMS central monitoring system has potential cybersecurity issues that could allow unauthorized access to patient monitoring data. The FDA issued a notice asking the company to address these vulnerabilities. About 195 units are affected.
- Contact your healthcare facility's IT or biomedical department if you use the MFM-CMS system
- Check your device serial number against the FDA's list of affected units
- Follow any updates or patches provided by Edan Diagnostics
- Do not delay critical patient monitoring while remediation is underway
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
195
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1150-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief