Reported Feb 5, 2025 · Completed
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM…
Accuray Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accuray Incorporated · 1240 Deming Way · Madison, WI · 53717-1954
Is this the product you have?
- 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 anywhere in the body when radiation treatment is indicated.
- Lot codes and dates
- This issue affects all CyberKnife Treatment Delivery Systems using the STC. UDI-DI Pending
- Unit numbers
212 of 212 codes
C0014C0042C0047C0056C0059C0064C0066C0071C0074C0076C0077C0085C0086C0089C0091C0092C0093C0099C0100C0101C0115C0117C0119C0131C0137C0140C0162C0166C0168C0172C0173C0174C0177C0181C0182C0186C0197C0200C0205C0234C0236C0239C0240C0241C0246C0254C0258C0259C0263C0266C0268C0270C0271C0274C0277C0280C0282C0286C0289C0291
- Amount recalled
- 212
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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