Device recall
Z-1498-2020: LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is…
FDA device recall · Class II · LivaNova USA Inc.
Key facts
| Recall number (Z-number) | Z-1498-2020 |
|---|---|
| Recall event | 85098 |
| Product | LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less. |
| Product code | DWC |
| Recalling firm | LivaNova USA Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2022 |
| 510(k) numbers | K052601 |
| FEI number | 1718850 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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