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

Recall date

October 18, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0571-2025

FDA classification

Class II

Brand / firm

LivaNova Deutschland GmbH

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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