Device recall
Z-1696-2019: CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b)…
FDA device recall · Class II · Accuray Incorporated
Key facts
| Recall number (Z-number) | Z-1696-2019 |
|---|---|
| Recall event | 82664 |
| Product | CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment… |
| Product code | IYE |
| Recalling firm | Accuray Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2021 |
| 510(k) numbers | K150873 |
| 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