Device recall
Z-1449-2015: Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter…
FDA device recall · Class II · Hansen Medical Inc
Key facts
| Recall number (Z-number) | Z-1449-2015 |
|---|---|
| Recall event | 70847 |
| Product | Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites. |
| Product code | DXX |
| Recalling firm | Hansen Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2015 |
| 510(k) numbers | K111004, K132369, K141614 |
| 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