FDA-Device2026-01-28Class IIPROCESSING DEFECT
Edan M3 Vital Signs Monitor recalled for potential cybersecurity vulnerabilities
What this means
The FDA identified potential cybersecurity issues with certain Edan Model M3 Vital Signs Monitors used in healthcare settings. These portable devices measure blood pressure, oxygen levels, and temperature. The company received an FDA notice about the vulnerability.
- If you use an Edan M3 monitor, contact Edan Diagnostics or your healthcare IT department to verify if your device is affected by checking your serial/lot number
- Ask about available security updates or patches from the manufacturer
- Follow any guidance provided by Edan Diagnostics or your healthcare facility regarding continued safe use
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
13934
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1142-2026Want us to check the next one for you?
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