Device recall
Z-1901-2018: Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b)…
FDA device recall · Class II · LivaNova USA
Key facts
| Recall number (Z-number) | Z-1901-2018 |
|---|---|
| Recall event | 80072 |
| Product | Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz |
| Product code | DWC |
| Recalling firm | LivaNova USA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2025 |
| 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