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U.S. Department of Health and Human Services

Class 2 Device Recall CyberKnife Treatment Planning System

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  Class 2 Device Recall CyberKnife Treatment Planning System see related information
Date Initiated by Firm July 06, 2010
Date Posted January 10, 2011
Recall Status1 Terminated 3 on October 04, 2011
Recall Number Z-0890-2011
Recall Event ID 56326
510(K)Number k091146  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product 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.
Code Information All products are affected.
Recalling Firm/
Manufacturer		 Accuray Inc
1310 Chesapeake Ter
Sunnyvale CA 94089-1100
For Additional Information Contact
408-716-4600
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 customersupport@accuray.com.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = ACCURAY, INC.
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