Class II — LivaNova Deutschland GmbH
| Recalling firm | LivaNova Deutschland GmbH |
|---|---|
| Registered facility | LivaNova Deutschland GmbH (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Quantity | 38 |
| Distribution | US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV. |
| Initiated | 2024-10-18 |
| Classified | 2024-11-27 |
| Recall number | Z-0571-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — LivaNova Deutschland GmbH (Z-0571-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95665/
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