Device recall
Z-2574-2014: FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-2574-2014 |
|---|---|
| Recall event | 68984 |
| Product | FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation. |
| Product code | MUJ |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2017 |
| 510(k) numbers | K013112 |
| FEI number | 1037831 |
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