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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 January 16, 2012
Date Posted February 23, 2012
Recall Status1 Terminated 3 on September 28, 2012
Recall Number Z-1098-2012
Recall Event ID 61045
510(K)Number K091999  
Product Classification Accelerator, linear, medical - Product Code IYE
Product CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System, versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3 with Ray-Tracing dose calculation.
Accuray Incorporated, Sunnyvale, CA.

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 Model number: P/N 025153
Recalling Firm/
Manufacturer		 Accuray Incorporated
1310 Chesapeake Ter
Sunnyvale CA 94089-1100
For Additional Information Contact Joy M. Sacmar
408-716-4651
Manufacturer Reason
for Recall		 An anomaly was discovered during internal regression testing, where the dose information is displayed incorrectly during treatment planning during a specific workflow using the optional 4D Ray Tracing dose calculation algorithm. As a result, it is possible that the dose calculation will display a lower dose than the intended dose prescribed for treatment delivery.
FDA Determined
Cause 2		 Software design
Action Accuray sent an "URGENT DEVICE CORRECTION" letter dated January 16, 2012 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides a work around to prevent the issue from happening. Contact Accuray Customer Support at 1-877-668-8667for questions regarding this notice.
Quantity in Commerce 207
Distribution Worldwide Distribution-USA (nationwide) and the countries of Korea, Hong Kong, China, Canada, Turkey, India, Russia, Italy, France, Belgium, Poland, Germany, Netherlands, United Kingdom, Spain, Greece, Saudi Arabia, Switzerland, Ukraine, Czech Republic, and Japan.
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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