Accuray CyberKnife Treatment System Recall: Loose Set Screws May Cause Couch Roll
Accuray recalls CyberKnife treatment systems with set screws that can loosen over time, potentially causing the treatment couch to roll. Affected units include specific product codes and serial numbers listed in the recall.
Use caution until it’s fixed
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
Contact the company
What happened, in plain English
Accuray is recalling CyberKnife Treatment Delivery Systems where set screws connecting the couch to the motor can loosen over time. This could cause the treatment couch to roll unexpectedly during radiation therapy, posing a risk of injury to patients or staff. Read more at govinfonow.com/recall/63185-accuray-cyberknife-treatment-system-recall-loose-set-screws-may-cause.
Source Summary by GovInfoNow · govinfonow.com/recall/63185-accuray-cyberknife-treatment-system-recall-loose-set-screws-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1272-2021
Cite this page
“Accuray CyberKnife Treatment System Recall: Loose Set Screws May Cause Couch Roll.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63185-accuray-cyberknife-treatment-system-recall-loose-set-screws-may-cause. Based on FDA recall #Z-1272-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1272-2021%22&limit=1).
Why it’s dangerous
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time. If the couch rolls unexpectedly during treatment, it could cause injury to patients or staff due to the movement of the radiation delivery system.
Who’s affected
Patients and medical staff using CyberKnife systems with the affected product codes or serial numbers listed in the recall. Those most at risk are individuals handling the equipment during radiation treatments.
How to tell if you have this one
Check if your CyberKnife Treatment Delivery System has product codes like 019200 or serial numbers starting with C0063 through C0513 as listed in the recall. The product is used for image-guided stereotactic radiosurgery and precision radiotherapy.
- Brand
Accuray- Category
Medical device
What to do — step by step
Check Product Details
Verify your CyberKnife system's product code or serial number against the list provided in the recall to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 33 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AK, AZ. CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV, PR and the countries of…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1272-2021 (February 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1272-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.