Device recall
Z-2818-2015: EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic…
FDA device recall · Class II · Olympus Corporation of the Americas
Key facts
| Recall number (Z-number) | Z-2818-2015 |
|---|---|
| Recall event | 72051 |
| Product | EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs. |
| Product code | ODG |
| Recalling firm | Olympus Corporation of the Americas |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 8, 2017 |
| 510(k) numbers | K093395 |
| 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