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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 September 12, 2011
Date Posted October 11, 2011
Recall Status1 Terminated 3 on February 27, 2012
Recall Number Z-0035-2012
Recall Event ID 59937
510(K)Number K102650  
Product Classification Accelerator, linear, medical - Product Code IYE
Product CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch).
Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185.
Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Code Information Model numbers 026429 and 028185. All units
Recalling Firm/
Manufacturer		 Accuray Incorporated
1310 Chesapeake Terrace
Sunnyvale CA 94089-1100
For Additional Information Contact Joy M. Sacmar
408-716-4651
Manufacturer Reason
for Recall		 A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged which allowed rotation and subsequent descent of the assembly.
FDA Determined
Cause 2		 Process control
Action Urgent Device Correction Letters were sent to all sites affected by the retrofit on September 12, 2011 via Fed Ex. The letter identified the affected product and the description of the potential problem. Customers were asked to inspect their Synchrony System by following the instructions provided. If the lower extension feels loose, customers should contact Accuray Customer Support immediately to schedule service of the system. The letter also states that all affected systems will be inspected and corrected, if necessary by Accuray to prevent the potential problem. Accuray Customer Support will contact customers to schedule the inspection. Questions or concerns regarding the issue should be directed to Accuray Customer Support at 1-877-8667 for US customers and 1-408-716-4700 for customers outside of the US, or customersupport@accuray.com.
Quantity in Commerce 236 total devices
Distribution Worldwide Distribution
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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