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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 Systemsee related information
Date Initiated by FirmOctober 30, 2008
Date PostedJanuary 14, 2009
Recall Status1 Terminated 3 on September 10, 2009
Recall NumberZ-0856-2009
Recall Event ID 50208
510(K)NumberK042146 
Product Classification Radiation Therapy Device - Product Code JAI
ProductRoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007, manufactured by Accuray Inc., Sunnyvale, CA The CyberKnife is indicated for treatment planning and imageguided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The RoboCouch Patient Support System is intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
Code Information Model number 025007, system numbers C0158, C0078, C0141, C0160, C0128, C0178, C0179, C0152, C0110, C0113, C0130, C0060, and C0125.
FEI Number 1000123585
Recalling Firm/
Manufacturer		 Accuray Inc
1310 Chesapeake Ter
Sunnyvale CA 94089
For Additional Information Contact
408-716-4600
Manufacturer Reason
for Recall		Product may not be tensioned properly, potentially causing unexpected rotation or descent.
FDA Determined
Cause 2		Process control
ActionAll affected sites were notified of the potential problem via Customer Advisory Notice dated 30 October 2008. The letter states required actions that the customer should follow at the beginning of each treatment day. The tension of the belt drive and the support bolts in question will be inspected by Accuray Field Service personnel at the affected facilities. In addition, the preventive maintenance procedure will be updated to include regular inspection and replacement of the belt-drive. Any questions or concerns regarding this issue should be directed to Accuray Customer Support at 1-877-668-8667 or 1-408-716-4700 or customersupport@accuray.com.
Quantity in Commerce13 units
DistributionWorldwide Distribution --- including USA and countries of France and Turkey.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAI
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