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U.S. Department of Health and Human Services

Class 2 Device Recall CyberKnife System Iris Variable Aperture Collimator

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  Class 2 Device Recall CyberKnife System Iris Variable Aperture Collimator see related information
Date Initiated by Firm March 19, 2013
Date Posted April 16, 2013
Recall Status1 Terminated 3 on October 23, 2013
Recall Number Z-1126-2013
Recall Event ID 64712
510(K)Number K122137  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
Code Information All units of these models.
Recalling Firm/
Manufacturer		 Accuray Incorporated
1310 Chesapeake Ter
Sunnyvale CA 94089-1100
For Additional Information Contact Joy M. Sacmar
408-716-4600
Manufacturer Reason
for Recall		 A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators.
FDA Determined
Cause 2		 Component design/selection
Action On 3/19/13, an "Urgent Device Correction Letter" was distributed to all affected users, with a description of the problem and user corrective action steps. US customers can contact 1-877- 668-8667 if questions.
Quantity in Commerce 176 units
Distribution Worldwide distribution, including Nationwide in the US and the countries of Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Spain, Switzerland, Turkey, Columbia, Mexico, Japan and Saudi Arabia.
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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