Device recall
Z-1616-2023: To be used with ultrasound endoscopes for ultrasound guided fine needle…
FDA device recall · Class III · Olympus Corporation of the Americas
Key facts
| Recall number (Z-number) | Z-1616-2023 |
|---|---|
| Recall event | 92129 |
| Product | To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A |
| Product code | FCG |
| Recalling firm | Olympus Corporation of the Americas |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K160098 |
| FEI number | 2429304 |
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