# FDA recall Z-1146-2026

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

## Product

Brand Name: EDAN  Product Name: Patient Monitor  Model/Catalog Number: elite V5, elite V6, elite V8  Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which 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 V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography).  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-1146-2026
- **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-1146-2026

## Citation

> AI Analytics. FDA recall Z-1146-2026. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-1146-2026. Source: US FDA. Licensed CC0.

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