Device recall
Z-1023-2025: CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be…
FDA device recall · Class II · Accuray Incorporated
Key facts
| Recall number (Z-number) | Z-1023-2025 |
|---|---|
| Recall event | 95814 |
| Product | CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions… |
| Product code | IYE |
| Recalling firm | Accuray Incorporated |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K170788 |
| FEI number | 3003873069 |
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