Essenz HLM — Class II medical device recall Z-0571-2025
Ongoing recall by LivaNova Deutschland GmbH, reported 2024-12-04, distributed nationwide. Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operatio
| Recall number | Z-0571-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova Deutschland GmbH, Munich, Germany |
| Recall initiated | 2024-10-18 |
| Classified | 2024-11-27 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 38 |
| UPC / GTIN / UDI-DI | 04033817903062 |
| Serial numbers | 49PK00091, 49PK00092, 49PK00093, 49PK00108, 49PK00163, 49PK00219, 49PK00223, 49PK00224, 49PK00225, 49PK00226, 49PK00241, 49PK00255, 49PK00273, 49PK00274, 49PK00275, 49PK00276, 49PK00277, 49PK00278, 49PK00288, 49PK00290, 49PK00291, 49PK00292, 49PK00293, 49PK00374, 49PK00436 and 13 more |
| Model numbers | 49-00-10 |
Product
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.