Device recall
Z-1897-2020: da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical…
FDA device recall · Class II · Intuitive Surgical Inc
Key facts
| Recall number (Z-number) | Z-1897-2020 |
|---|---|
| Recall event | 83482 |
| Product | da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its primary function is to… |
| Product code | NAY |
| Recalling firm | Intuitive Surgical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 8, 2024 |
| 510(k) numbers | K171294 |
| 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