Recall Z-0890-2011 · MUJ System, Planning, Radiation Therapy Treatment

Accuray Inc

CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device, manufactured by Accuray Inc., Sunnyvale, CA. Medical device indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

Date	Jan 10, 2011 (initiated Jul 6, 2010)
Status	Terminated
Reason	Latches responsible for securing the cover to the device may come lose if not properly secured and the cover may unexpectedly drop off. A design change is planned.
Root cause	Device Design
Action	Accuray sent an "URGENT DEVICE CORRECTION" letter dated July 6, 2010, to all customers. The letter described the product, problem and actions to be taken by customers. The customers were instructed to assure the LINAC cover is secure following reattachment and adhere to and follow the instructions included in the letter. Note: A new design is being developed, and will be distributed to user base once available. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at +1-877-668-8667 (USA) or +1-408-716-4700 (non-USA) or custom
Quantity	207 units
Distribution	Worldwide distribution: US including: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV, and countries including: Japan, China, Vietnam, Taiwan/China, South Korea, Hong Kong/China, Thailand and Malaysia.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K091146

MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
Accuray, Inc., May 1, 2009