Edan Diagnostics: Device Recall

Recall #Z-1154-2026 · 10/24/2025

Class II: Risk

Recall Details

Recall Number
Z-1154-2026
Classification
Class II
Product Type
Device
Recalling Firm
Edan Diagnostics
Status
Ongoing
Date Initiated
10/24/2025
Location
San Diego, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3141

Reason for Recall

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.

Product Description

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

Distribution Pattern

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.

Other Recalls by Edan Diagnostics

View all recalls by Edan Diagnostics →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.