Device recall
Z-1564-2016: Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80…
FDA device recall · Class II · Hansen Medical Inc
Key facts
| Recall number (Z-number) | Z-1564-2016 |
|---|---|
| Recall event | 73677 |
| Product | Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away… |
| Product code | DXX |
| Recalling firm | Hansen Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 6, 2016 |
| 510(k) numbers | K111004, K132369, K141614, K151730 |
| 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