Use cautionMedical device recall · FDA · Published December 23, 2024
Accuray CyberKnife System Recall: Snap Rings May Detach Causing Uncontrolled Rotation
Accuray recalls CyberKnife Treatment Delivery Systems with specific unit numbers due to snap rings that may detach, causing uncontrolled rotation and potential safety risks during radiation therapy procedures.
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.
Take action
Contact the company
📍Recalling firmAccuray Incorporated1240 Deming Way · Madison, WI 53717-1954
“Accuray CyberKnife System Recall: Snap Rings May Detach Causing Uncontrolled Rotation.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53175-accuray-cyberknife-system-recall-snap-rings-may-detach-causing-uncontrolled. Based on FDA recall #Z-1023-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1023-2025%22&limit=1).
The FDA announced on Dec. 23, 2024, that Accuray Incorporated is recalling its CyberKnife Treatment Delivery Systems due to potential uncontrolled rotation of internal axes. Owners should contact the company for inspection and repair.
Also labeled as: CyberKnife M6TM or VSI TM Robotic Surgery System
Unit numbers: C0014 through C0612 (specific list provided in record)
Distribution: Worldwide
The hazard
Snap rings may become partially or completely detached from the shafts within the internal mechanism, potentially causing uncontrolled rotation on the left and right roll axes when the rings are removed or damaged.
Context
GovInfoNow's records show Accuray has issued 9 other recalls since Nov. 17, 2017. Recent Accuray recalls include a June 16, 2026 notice regarding collimator docking issues and an Aug. 3, 2023 alert about upper roller bracket clearance on the Radixact System. Other recent recalls of similar products include Medline medical convenience kits (Feb. 27, 2026), Merit Medical Custom Procedure Kit (Dec. 4, 2025), and Canon Alphenix INFX-8000F X-Ray System (Dec. 19, 2025).
How to tell if you have this one
Check if your CyberKnife Treatment Delivery System is labeled as CyberKnife M6 or VSI. The affected units have specific serial numbers listed in the recall (e.g., C0014, C0042, etc.).
Brand
Accuray
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Unit Numbers
Identify if your CyberKnife system has a unit number from the list provided in the recall (e.g., C0014, C0042, etc.).
Contact Accuray
Reach out to Accuray for further instructions if your unit number is on the recall list.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1023-2025 (December 23, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1023-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.