FDA Device

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.

Hazard

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.

What You Should Do

Remedy

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 customersupport@accuray.com.

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Products

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 tre
Brand
Accuray Inc
UPC
All products are affected.

Units Affected

207 units

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