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FDA-Device2026-01-28Class IIPROCESSING DEFECT

Edan iM8 patient monitors recalled for cybersecurity vulnerabilities

Edan Diagnostics
OTHERNationwide distribution

Check Edan iM8 patient monitor security

The FDA identified potential cybersecurity issues with Edan iM8, iM8A, and iM8B patient monitors. These devices are used in medical settings to continuously monitor heart rhythm, blood oxygen, blood pressure, and other vital signs. The vulnerability could potentially allow unauthorized access to the device or its data.

  • If your facility uses an Edan iM8, iM8A, or iM8B monitor, check the serial number against the recall list
  • Contact Edan Diagnostics or your device representative for guidance on security updates or replacement
  • Do not discontinue use without consulting your IT or clinical engineering team for continuity of patient monitoring
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
3141
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor 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 abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models. iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement. iM8 Series patient monitor includes three models iM8, iM8A, iM8B, and screen size is the primary difference for three models. Component: No

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1154-2026

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