# FDA recall Z-1149-2026

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

## Product

Brand Name: EDAN  Product Name: Patient Monitor  Model/Catalog Number: iX10, iX12, iX15  Product Description: The iX series Patient Monitors including iX10, iX12, iX15 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 abnormalities so that doctors and nurses can respond to the patient's situation as appropriate.  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-1149-2026
- **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-1149-2026

## Citation

> AI Analytics. FDA recall Z-1149-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1149-2026. Source: US FDA. Licensed CC0.

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