Device recall
Z-1255-06: ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-1255-06 |
|---|---|
| Recall event | 35742 |
| Product | ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System; a table tilt device - powered radiation therapy patient support assembly; BrainLab AG… |
| Product code | JAI |
| Recalling firm | Brainlab AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2008 |
| 510(k) numbers | K033316 |
| FEI number | 3002619595 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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