Device recall
Z-1424-2013: User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS…
FDA device recall · Class II · Intuitive Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-1424-2013 |
|---|---|
| Recall event | 65094 |
| Product | User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral… |
| Product code | NAY |
| Recalling firm | Intuitive Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 30, 2013 |
| 510(k) numbers | K090993 |
| 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