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U.S. Department of Health and Human Services

Class 2 Device Recall CyberKnife Robotic Radiosurgery System

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  Class 2 Device Recall CyberKnife Robotic Radiosurgery System see related information
Date Initiated by Firm October 28, 2010
Date Posted December 16, 2010
Recall Status1 Terminated 3 on April 01, 2011
Recall Number Z-0714-2011
Recall Event ID 57236
510(K)Number K091999  
Product Classification Accelerator, linear, medical - Product Code IYE
Product CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA.

Indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Code Information All versions
Recalling Firm/
Manufacturer		 Accuray Inc
1310 Chesapeake Ter
Sunnyvale CA 94089-1100
For Additional Information Contact
408-716-4600
Manufacturer Reason
for Recall		 If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated.
FDA Determined
Cause 2		 Other
Action Accuray Inc., sent an "URGENT DEVICE CORRECTION" letter dated October 21, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to increase the size of the dose box to include CT volume, not just the contoured anatomy; recalculate dose at high resolution, and examine the treatment plan to ensure that applicable organs at risk are accounted for and all portions of the patient receive the desired level of doses. 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), +1-408-716-4700 (non-USA) or email: customersupport@accuray.com.
Quantity in Commerce 219 units
Distribution USA and countries of: Athens, Belgium, Canada, China, Czech Republic, France, Germany, India, Italy, Japan, Korea, Malaysia, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Thailand, The Netherland, Turkey, Ukraine, United Kingdom, Vietnam, Venezuela.
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 = IYE and Original Applicant = ACCURAY, INC.
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