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.
This recall has been terminated (originally issued September 14, 2009).
- Company
- Accuray Inc
- Recall Initiated
- June 22, 2009
- Posted
- September 14, 2009
- Terminated
- January 5, 2011
- Recall Number
- Z-1810-2009
- Quantity
- 61 units
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.
Distribution
Worldwide Distribution -- US including states of MA, FL, AL, TN, DE, CA, NJ, OK, CO, NC, IL, PA, MD, DC, MS, CN, NV, RI, SC, UT, VA, MI, NE, MO, TX and AL and countries of Canada, Russia, UK, Ukraine, Saudi Arabia, Switzerland, Turkey, Taiwan, India, China, Korea and Thailand.
Lot / Code Info
All system Serial Numbers C128 and higher with 2005 edition Robot Controller.
Root Cause
Software design
Action Taken
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.