Device recall
Z-2435-2021: Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01)…
FDA device recall · Class II · NIHON KOHDEN ORANGEMED, INC
Key facts
| Recall number (Z-number) | Z-2435-2021 |
|---|---|
| Recall event | 88411 |
| Product | Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. |
| Product code | CBK |
| Recalling firm | NIHON KOHDEN ORANGEMED, INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 21, 2023 |
| 510(k) numbers | K181695, K192307 |
| FEI number | 3014631252 |
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