FDA-Device2024-12-04Class II
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
LivaNova Deutschland GmbH
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.
Sold states
US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.
Affected count
38
Manufactured in
Lindberghstr. 25, Munich, Germany
Products
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0571-2025Don't want to check this manually?
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