Device recall
Z-0896-2015: Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint…
FDA device recall · Class II · Hansen Medical Inc
Key facts
| Recall number (Z-number) | Z-0896-2015 |
|---|---|
| Recall event | 69855 |
| Product | Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and… |
| Product code | DXX |
| Recalling firm | Hansen Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 3, 2015 |
| 510(k) numbers | K052480, K073225, K091808, K102168 |
| FEI number | 3006026430 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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