Device recall
Z-0088-2014: da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which…
FDA device recall · Class II · Intuitive Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-0088-2014 |
|---|---|
| Recall event | 66434 |
| Product | da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. |
| Product code | NAY |
| Recalling firm | Intuitive Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 28, 2013 |
| 510(k) numbers | K081137 |
| FEI number | 3001675293 |
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