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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 June 22, 2009
Date Posted September 14, 2009
Recall Status1 Terminated 3 on January 05, 2011
Recall Number Z-1810-2009
Recall Event ID 52643
510(K)Number K072504  
Product Classification Accelerator, linear, medical - Product Code IYE
Product 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.
Code Information All system Serial Numbers C128 and higher with 2005 edition Robot Controller.
Recalling Firm/
Manufacturer		 Accuray Inc
1310 Chesapeake Ter
Sunnyvale CA 94089-1100
For Additional Information Contact
408-716-4600
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action 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.
Quantity in Commerce 61 units
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.
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 INCORPORATED
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