Accuray Inc CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment for planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment for planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Brand
Accuray Inc
Lot Codes / Batch Numbers
All system Serial Numbers C128 and higher with 2005 edition Robot Controller.
Products Sold
All system Serial Numbers C128 and higher with 2005 edition Robot Controller.
Accuray Inc is recalling CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, man due to Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.
Recommended Action
Per FDA guidance
Accuray, Inc. issued an "Urgent Device Correction" notice dated June 22, 2009. The consignees were informed of the defect including methods for detecting the error. The firm is in the process of developing a software patch to address the issue. For further information, contact Accuray, Inc. Customer Support at +1-877-668-8667 (US) or +1-408-716-4700 (outside US) or customersupport@accuray.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CO, DE, FL, IL, MD, MA, MI, MS, MO, NE, NV, NJ, NC, OK, PA, RI, SC, TN, TX, UT, VA, DC
Page updated: Jan 10, 2026