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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 November 14, 2008
Date Posted January 17, 2009
Recall Status1 Terminated 3 on December 02, 2010
Recall Number Z-0629-2009
Recall Event ID 50207
510(K)Number K072504  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0.

Product is 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 units that have MP software version 3.0 and the Iris Collimator in clinical use at the same time are subject to this recall.
Recalling Firm/
Manufacturer		 Accuray Inc
1310 Chesapeake Ter
Sunnyvale CA 94089-1100
For Additional Information Contact
408-716-4600
Manufacturer Reason
for Recall		 System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of correct dose which may lead to serious patient injury.
FDA Determined
Cause 2		 Software design
Action An Urgent Advisory Notification letter dated November 14, 2008 was issued to all sites via Fed Ex. The letter identifies the issue and required actions. The user was instructed not to modify current extrapolation depth settings and to contact Accuray Incorporated Customer Support prior to making any changes. Please direct any questions or concerns regarding this issue to Accuray Incorporated Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (outside of USA) or customersupport@accuray.com.
Quantity in Commerce 4 units
Distribution Nationwide Distribution. Product was distributed to 4 medical facilities in the US.
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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