Device recall
Z-1142-2015: EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da…
FDA device recall · Class II · Intuitive Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-1142-2015 |
|---|---|
| Recall event | 70467 |
| Product | EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for… |
| Product code | NAY |
| Recalling firm | Intuitive Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 1, 2015 |
| 510(k) numbers | K140189 |
| 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