Device recall
Z-0551-2022: Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves…
FDA device recall · Class II · Olympus Corporation of the Americas
Key facts
| Recall number (Z-number) | Z-0551-2022 |
|---|---|
| Recall event | 89333 |
| Product | Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00 |
| Product code | NJK |
| Recalling firm | Olympus Corporation of the Americas |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P180007 |
| FEI number | 2429304 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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