Device recall
Z-0714-2011: CyberKnife Robotic Radiosurgery System, medical charged-particle radiation…
FDA device recall · Class II · Accuray Inc
Key facts
| Recall number (Z-number) | Z-0714-2011 |
|---|---|
| Recall event | 57236 |
| Product | CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when… |
| Product code | IYE |
| Recalling firm | Accuray Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2011 |
| 510(k) numbers | K091999 |
| 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