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U.S. Department of Health and Human Services

Class 2 Device Recall Varian brand Clinac, Trilogy, Novalis Tx Unique, linear accelerators

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  Class 2 Device Recall Varian brand Clinac, Trilogy, Novalis Tx Unique, linear accelerators see related information
Date Initiated by Firm August 14, 2012
Date Posted September 14, 2012
Recall Status1 Terminated 3 on December 04, 2013
Recall Number Z-2383-2012
Recall Event ID 63033
510(K)Number K926321  K081188  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA.

1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Code Information LIST OF SERIAL NUMBERS:  H140863 ,H294608 ,H294669 ,H294732 ,H140865 ,H294610 ,H294670 ,H294733 ,H140866 ,H294611 ,H294671 ,H294734 ,H140867 ,H294612 ,H294672 ,H294735 ,H140868 ,H294613 ,H294673 ,H294736 ,H140869 ,H294614 ,H294674 ,H294737 ,H140870 ,H294615 ,H294675 ,H294738 ,H140871 ,H294616 ,H294676 ,H294739 ,H140872 ,H294617 ,H294677 ,H294740 ,H140873 ,H294618 ,H294678 ,H294741 ,H140874 ,H294619 ,H294679 ,H294742 ,H140875 ,H294620 ,H294680 ,H294743 ,H140876 ,H294621 ,H294681 ,H294744 ,H140877 ,H294622 ,H294682 ,H294745 ,H140878 ,H294623 ,H294683 ,H294746 ,H140879 ,H294624 ,H294684 ,H294747 ,H140880 ,H294625 ,H294685 ,H294748 ,H140881 ,H294626 ,H294686 ,H294749 ,H140882 ,H294627 ,H294687 ,H294750 ,H140883 ,H294628 ,H294688 ,H294751 ,H140884 ,H294629 ,H294689 ,H294752 ,H140885 ,H294630 ,H294690 ,H294753 ,H140886 ,H294631 ,H294691 ,H294754 ,H140887 ,H294632 ,H294692 ,H294755 ,H140888 ,H294633 ,H294693 ,H294756 ,H140889 ,H294634 ,H294694 ,H294757 ,H140890 ,H294635 ,H294695 ,H294758 ,H140891 ,H294636 ,H294696 ,H294759 ,H140892 ,H294637 ,H294697 ,H294760 ,H140893 ,H294638 ,H294698 ,H294761 ,H140895 ,H294639 ,H294699 ,H294762 ,H140896 ,H294640 ,H294700 ,H294763 ,H140897 ,H294641 ,H294701 ,H294764 ,H140898 ,H294642 ,H294702 ,H294765 ,H140899 ,H294643 ,H294704 ,H294766 ,H140900 ,H294644 ,H294705 ,H294767 ,H181175 ,H294645 ,H294706 ,H294768 ,H181176 ,H294646 ,H294707 ,H294769 ,H181177 ,H294647 ,H294708 ,H294770 ,H181178 ,H294648 ,H294709 ,H294771 ,H181179 ,H294649 ,H294710 ,H294772 ,H181180 ,H294650 ,H294711  ,H181181 ,H294651 ,H294712  ,H181182 ,H294652 ,H294713  ,H181183 ,H294653 ,H294714  ,H181184 ,H294654 ,H294715  ,H181185 ,H294655 ,H294716  ,H181186 ,H294656 ,H294717  ,H181187 ,H294657 ,H294718  ,H181188 ,H294658 ,H294719  ,H181189 ,H294659 ,H294720  ,H181190 ,H294660 ,H294722  ,H181191 ,H294661 ,H294723  ,H181192 ,H294662 ,H294724  ,H182000 ,H294663 ,H294726  ,H182001 ,H294664 ,H294727  ,H182002 ,H294665 ,H294728  ,H182003 ,H294666 ,H294729  ,H182005 ,H294667 ,H294730  ,H294607 ,H294668 ,H294731    
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Peter J. Coronado
650-493-4000
Manufacturer Reason
for Recall		 Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The position readout interlock circuitry will not detect this jaw position deviation. This may lead to treatment with an under-dose of the intended target volume.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Varian sent an "URGENT MEDICAL DEVICE CORRECTION URGENT FIELD SAFETY NOTICE" dated August 14, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-888-827-4265 for questions regarding this recall.
Quantity in Commerce 221 Units
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 = VARIAN ASSOC., INC.
510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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