Device recall
Z-1126-2013: Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System…
FDA device recall · Class II · Accuray Incorporated
Key facts
| Recall number (Z-number) | Z-1126-2013 |
|---|---|
| Recall event | 64712 |
| Product | Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment. |
| Product code | IYE |
| Recalling firm | Accuray Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 23, 2013 |
| 510(k) numbers | K122137 |
| 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