Device recall
Z-0747-2012: Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used…
FDA device recall · Class II · Olympus America Inc.
Key facts
| Recall number (Z-number) | Z-0747-2012 |
|---|---|
| Recall event | 60548 |
| Product | Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures during flexible gastrointestinal endoscopy. |
| Product code | GEI |
| Recalling firm | Olympus America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 1, 2013 |
| 510(k) numbers | K073207 |
| FEI number | 2429304 |
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