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FDA-Device2026-01-28Class IIPROCESSING DEFECT

Edan iM20 patient monitor recalled for cybersecurity vulnerabilities

Edan Diagnostics
OTHERNationwide distribution

Check your Edan iM20 patient monitor

The FDA identified potential cybersecurity issues with Edan's iM20 patient monitor system, which is used in hospitals and during patient transport to track vital signs like heart rhythm, blood pressure, and oxygen levels. The company received an FDA letter about these vulnerabilities. No injuries have been reported.

  • Contact Edan Diagnostics or your hospital IT department if you operate an affected iM20 monitor
  • Check if your device serial number matches the recall list
  • Follow any guidance from Edan Diagnostics or your healthcare facility regarding software updates or mitigation steps
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
377
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1147-2026

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