Use cautionMedical device recall · FDA · Published June 16, 2026
Accuray Cyberknife System Recall: Collimator May Fall During Treatment
Accuray recalls Cyberknife treatment systems with specific software versions due to risk of collimator falling during treatment. Affected units may require repair or replacement to prevent injury.
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Take action
Contact the company
📍Recalling firmAccuray Incorporated1240 Deming Way · Madison, WI 53717-1954
“Accuray Cyberknife System Recall: Collimator May Fall During Treatment.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49003-accuray-cyberknife-system-recall-collimator-may-fall-during-treatment. Based on FDA recall #Z-2640-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2640-2026%22&limit=1).
The FDA announced on June 16, 2026, that Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer due to a risk of collimator detachment. The agency issued recall number Z-2640-2026 for the voluntary Class II action affecting 48 units distributed worldwide.
How to tell if you have it
Brand: Accuray
Product: Cyberknife Treatment Delivery System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Software version: 11X
Quantity: 48 units
The hazard
According to the FDA, a collimator may not fully dock, triggering a system interlock that prevents motion from the operator console. If personnel enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Context
GovInfoNow's records show Accuray Incorporated has 9 other recalls on record since November 17, 2017. Other recent recalls of similar products include Canon Alphenix INFX-8000C X-ray System Recall (December 19, 2025), GE Maxxus Nuclear Medicine Systems Recall (December 10, 2025), and Canon Alphenix X-ray Systems Recall (August 4, 2026).
How to tell if you have this one
Check if your Cyberknife system has software version 11X that uses the Exchange Table. The recall covers all systems with this specific software configuration.
Brand
Accuray
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your Cyberknife system's software version to see if it matches the recalled version (11X with Exchange Table).
Contact Manufacturer
Reach out to Accuray for guidance on next steps if your system is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of China, Colombia, Czech Republic, France, Hong Kong, Japan, Korea, Republic of, Latvia, Mexico, Myanmar, Saudi Arabia, Taiwan, Turkey, Ukraine.” 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 22 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-2640-2026 (June 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2640-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.