Device recall
Z-0771-2016: CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover…
FDA device recall · Class II · Accuray Incorporated
Key facts
| Recall number (Z-number) | Z-0771-2016 |
|---|---|
| Recall event | 73193 |
| Product | CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the… |
| Product code | IYE |
| Recalling firm | Accuray Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 20, 2016 |
| 510(k) numbers | K120233 |
| 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