Device recall
Z-1119-2020: LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly…
FDA device recall · Class III · LivaNova USA Inc.
Key facts
| Recall number (Z-number) | Z-1119-2020 |
|---|---|
| Recall event | 84142 |
| Product | LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. |
| Product code | DTQ |
| Recalling firm | LivaNova USA Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 31, 2022 |
| 510(k) numbers | K071318 |
| FEI number | 1718850 |
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