Accuray Incorporated recalls Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer
- Recalling company
- Accuray Incorporated
- Product
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Jun 16, 2026
- Reported
- Jul 8, 2026
- 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.
- Status
- Ongoing
- Quantity
- 292 units
- Lot / codes
- ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table.
- Company location
- Madison, WI
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2644-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2644-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.