Lower riskMedical device recall · FDA · Published September 26, 2018
Accuray CyberKnife M6 Systems Recall: Manufacturing Variations May Cause Premature Failure
Accuray recalls CyberKnife M6 Systems with specific serial numbers due to potential manufacturing variations that could lead to premature component failure. Affected units include 60+ models with serial numbers starting with C0330 to C0464.
A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of the component.
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Contact the company
📍Recalling firmAccuray Incorporated1240 Deming Way · Madison, WI 53717-1954
“Accuray CyberKnife M6 Systems Recall: Manufacturing Variations May Cause Premature Failure.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69765-accuray-cyberknife-m6-systems-recall-manufacturing-variations-may-cause-premature. Based on FDA recall #Z-0408-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0408-2019%22&limit=1).
The FDA announced on Sept. 26, 2018, that Accuray Incorporated is recalling CyberKnife M6 systems due to a potential component failure hazard. The agency issued the Class II recall for devices with specific serial numbers distributed worldwide.
A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of the component.
Context
GovInfoNow's records show Accuray Incorporated has had 9 other recalls on record since Nov. 17, 2017. Other recent recalls include an Accuray Cyberknife System recall regarding a collimator that may fall during treatment (June 16, 2026) and another for snap rings that may detach causing uncontrolled rotation (Dec. 23, 2024). Similar product recalls in the sector include an Acumed Hexalob Screw recall for risk of breakage (May 28, 2026), a Zeiss Intrabeam Spherical Applicator recall for manufacturing defect (June 1, 2026), and a Da Vinci X and Xi Surgical Systems recall for broken manipulator screws (April 2, 2026).
How to tell if you have this one
Check if your CyberKnife M6 System has a serial number starting with C0330 through C0464. The product is used for radiation treatment planning and stereotactic radiosurgery.
Brand
Accuray
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Verify your CyberKnife M6 System's serial number to see if it matches the list of affected numbers starting with C0330 through C0464.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0408-2019 (September 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0408-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.