Medical Device Recall: Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
LivaNova Deutschland GmbH · October 18, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
38
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0571-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.