Device recall
Z-0220-2020: SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product…
FDA device recall · Class II · LivaNova USA Inc.
Key facts
| Recall number (Z-number) | Z-0220-2020 |
|---|---|
| Recall event | 83822 |
| Product | SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The Stckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: " Two circuits for the patient… |
| 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