Device recall
Z-2596-2011: Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01…
FDA device recall · Class II · Computerized Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-2596-2011 |
|---|---|
| Recall event | 58256 |
| Product | Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability… |
| Product code | MUJ |
| Recalling firm | Computerized Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2014 |
| 510(k) numbers | K013112 |
| FEI number | 1937649 |
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