Class 2 Device Recall CyberKnife System Robotic Radiosurgery System

• Date Initiated by Firm: March 16, 2009
• Date Posted: January 18, 2011
• Recall Status: Terminated on January 19, 2011
• Recall Number: Z-0908-2011
• Recall Event ID: 51550
• 510(K)Number: K020294 K072504
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: CyberKnife System Robotic Radiosurgery 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 A Radiation therapy device.
• Code Information: All units of these models.
• Recalling Firm/ Manufacturer: Accuray Inc; 1310 Chesapeake Ter; Sunnyvale CA 94089-1100
• For Additional Information Contact: 408-716-4600
• Manufacturer Reason for Recall: The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious injury if the boom descends unexpectedly.
• FDA Determined Cause: Device Design
• Action: Accuracy Inc., sent an URGENT ADVISORY NOTIFICATION letter, dated March 16, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their system to see if it was affected. Customers were instructed to contact Accuracy Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 or e-mail customersupport@accuracy.com to schedule service.
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Turkey, Russia, France, Italy, the Netherlands, the UK, Spain, Greece, Switzerland, Germany, India, Taiwan, China, Hong Kong, Korea, Thailand, Malaysia 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; 510(K)s with Product Code = IYE