Device recall
Z-0218-2015: CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable…
FDA device recall · Class II · Accuray Incorporated
Key facts
| Recall number (Z-number) | Z-0218-2015 |
|---|---|
| Recall event | 69645 |
| Product | CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation… |
| Product code | IYE |
| Recalling firm | Accuray Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 20, 2015 |
| 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