Device recall
Z-1008-2011: CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic…
FDA device recall · Class II · Accuray Inc
Key facts
| Recall number (Z-number) | Z-1008-2011 |
|---|---|
| Recall event | 54535 |
| Product | CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5 Medical charged-particle radiation therapy system, intended for treatment planning and image-guided stereotactic radiosurgery and precision… |
| Product code | MUJ |
| Recalling firm | Accuray Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 11, 2011 |
| 510(k) numbers | K091146 |
| FEI number | 1000123585 |
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