Device recall
Z-0111-2014: Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The…
FDA device recall · Class II · Intuitive Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-0111-2014 |
|---|---|
| Recall event | 66524 |
| Product | Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic… |
| Product code | NAY |
| Recalling firm | Intuitive Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 4, 2014 |
| 510(k) numbers | K112208 |
| 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