Device recall
Z-0571-2025: Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
FDA device recall · Class II · LivaNova Deutschland GmbH
Key facts
| Recall number (Z-number) | Z-0571-2025 |
|---|---|
| Recall event | 95665 |
| Product | Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software |
| Product code | DTQ |
| Recalling firm | LivaNova Deutschland GmbH |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K232291 |
| FEI number | 3002808267 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database