# FDA recall Z-1154-2026

> **Edan Diagnostics** · Class II · device recall initiated 2025-10-24.

## Product

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

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1154-2026
- **Recalling firm:** Edan Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-24
- **Report date:** 2026-01-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1154-2026. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-1154-2026. Source: US FDA. Licensed CC0.

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