CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robo
FDA device recall Z-1023-2025 · posted 2025-01-27 · Completed
Recall details
- Recalling firm
- Accuray Incorporated
- Reason for recall
- Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.
- Action taken
- On December 23, 2024, the firm began notifying customers via Urgent Field Safety Notice letters. Customers were informed that they may continue to use the CyberKnife System clinically, but were reminded to ensure patients are attended when positioning, re-positioning, and leaving the STC. Starting in December, Accuray Customer support will contact customers to schedule service to provide a full inspection and to replace the existing snap rings on the affected retention mechanism of the STC.
- Root cause
- Component design/selection
- Status
- Completed
- Product code
- IYE
- Quantity affected
- 212
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2024-12-23
- Date posted
- 2025-01-27
- Location
- Madison, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CyberKnife Treatment Delivery System (K170788) | Accuray Incorportaed | 2017-04-11 |