Quick Facts at a Glance
- Recall Date
- June 16, 2026
- Hazard Level
- HIGH
- Brand
- Accuray
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Accuray
- Model numbers
- ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table.
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 16, 2026
Reported by FDA DEVICE
July 8, 2026
RecallRadar source check
July 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Accuray Incorporated or your healthcare provider for instructions. Notification method: Letter
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Full Description
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator. Reason: 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.. Classification: Class II. Quantity: 292 units. 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 of, Liechtenstein, Lithuania, Luxembourg, Macao, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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