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LivaNova Deutschland GmbH recalls Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Recalled December 4, 2024 · FDA recall Z-0571-2025 · LivaNova Deutschland
Hazard
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. · FDA Class II
Units
38
Sold at
US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.
Description
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.
Product
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Manufacturer(s)
LivaNova Deutschland GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →