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U.S. Department of Health and Human Services

Class 2 Device Recall CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option.

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  Class 2 Device Recall CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. see related information
Date Initiated by Firm November 07, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on February 27, 2012
Recall Number Z-0382-2012
Recall Event ID 60437
510(K)Number K091999  
Product Classification Accelerator, linear, medical - Product Code IYE
Product CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option.

The CyberKnife treatment is indicated for the 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: PN 032384
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		 User Facility reported an anomaly where inhale and exhale CT pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery.
FDA Determined
Cause 2		 Labeling design
Action Accuray sent a Urgent Medical Device Correction letter dated November 7, 2011, via Federal Express to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The information provided in this letter will be incorporated in user manuals shipped with the CyberKnife system. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at 1. (877) 668-8667 ( USA) 1. (408) 716-4700 ( non USA )
Quantity in Commerce 30
Distribution Worldwide Distribution -- USA ( nationwide ) including the states of FL, TN, IL, NJ, CO, PA, MD, CA, MS, MN, SC, WA, OK, GA, AZ, and TX., and the countries of France and United Kingdom.
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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