Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CyberKnife Robotic Radiosurgery System using software version 10.6 Recalled by Accuray Incorporated Due to Accuray has become aware of a potential safety...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Accuray Incorporated directly.
Affected Products
CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Quantity: 40 affected devices
Why Was This Recalled?
Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife¿ Systems with software version 1 0.6.
Where Was This Sold?
This product was distributed to 12 states: AK, CA, FL, KY, MN, MT, NJ, NY, PA, SC, WA, WI
About Accuray Incorporated
Accuray Incorporated has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report