# FDA recall Z-0571-2025

> **LivaNova Deutschland GmbH** · Class II · device recall initiated 2024-10-18.

## Product

Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

## Reason for recall

Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.

## Distribution

US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.

## Key facts

- **Recall number:** Z-0571-2025
- **Recalling firm:** LivaNova Deutschland GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-18
- **Report date:** 2024-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munich, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0571-2025

## Citation

> AI Analytics. FDA recall Z-0571-2025. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-0571-2025. Source: US FDA. Licensed CC0.

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