Use caution Medical device recall · FDA · Published June 16, 2026

Accuray Cyberknife System Recall: Collimator May Fall During Treatment

Accuray recalls Cyberknife systems with specific software versions where a collimator could fall during treatment, posing a risk of injury. Affected units include those with Xchange Robotic Collimator Changer and Linear Accelerator running software 11.X or higher.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2644-2026Medical device Accuray ›

Use caution until it’s fixed

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

✎ GovInfoNow plain-language explainer

Accur: Accuray has recalled Cyberknife treatment systems with certain software versions. If the collimator doesn't dock properly, it could fall during treatment, potentially causing injury to staff. Read more at govinfonow.com/recall/49002-accuray-cyberknife-system-recall-collimator-may-fall-during-treatment.

Source Summary by GovInfoNow · govinfonow.com/recall/49002-accuray-cyberknife-system-recall-collimator-may-fall-during-treatment · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2644-2026

Cite this page

“Accuray Cyberknife System Recall: Collimator May Fall During Treatment.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49002-accuray-cyberknife-system-recall-collimator-may-fall-during-treatment. Based on FDA recall #Z-2644-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2644-2026%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. The hazard involves a collimator potentially falling from its housing if it fails to fully dock and personnel use the in-room control pendant.

How to tell if you have it

Brand: Accuray
Product: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Software: Version 11.X and higher that utilize the Exchange Table
Quantity: 292 units

The hazard

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 X-ray Systems Recall: Loose Fixing Screws Risk Equipment Failure (August 4, 2026), Canon Alphenix INFX-8000C X-ray System Recall: Ceiling Movement May Become Unstable (December 19, 2025), and Merit Medical Custom Procedure Kit Recall: Handle May Detach During Use (December 4, 2025).

How to tell if you have this one

Check if your Cyberknife system has the Xchange Robotic Collimator Changer and Linear Accelerator. Affected units run software version 11.X or higher.

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; affected units run version 11.X or higher.
Stop Using If Unstable
If the collimator does not dock properly, stop using the system immediately and contact Accuray.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide - US Nationwide and and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kenya, Korea, Republic…” 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.

Jun 16, 2026Firm started the recall
Jul 1, 2026FDA classified it Class II
Jul 8, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/49002-accuray-cyberknife-system-recall-collimator-may-fall-during-treatment">Accuray Cyberknife System Recall: Collimator May Fall During Treatment (GovInfoNow)</a>

Where this comes from

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-2644-2026 (June 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2644-2026 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.