Device recall
Z-1697-2019: CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic…
FDA device recall · Class II · Accuray Incorporated
Key facts
| Recall number (Z-number) | Z-1697-2019 |
|---|---|
| Recall event | 82664 |
| Product | CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System |
| Product code | IYE |
| Recalling firm | Accuray Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2021 |
| 510(k) numbers | K919999 |
| 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