Device recall
Z-0029-2012: OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle…
FDA device recall · Class II · Olympus America Inc.
Key facts
| Recall number (Z-number) | Z-0029-2012 |
|---|---|
| Recall event | 59787 |
| Product | OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and… |
| Product code | FCG |
| Recalling firm | Olympus America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2012 |
| 510(k) numbers | K050503 |
| 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