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U.S. Department of Health and Human Services

Class 2 Device Recall Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear

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  Class 2 Device Recall Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear see related information
Date Initiated by Firm May 13, 2011
Date Posted July 11, 2011
Recall Status1 Terminated 3 on July 13, 2012
Recall Number Z-2778-2011
Recall Event ID 58970
510(K)Number K033343  K100890  
Product Classification Linear Accelerator for Radiation Therapy System - Product Code IYE
Product Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands

Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Code Information H14, H19, H27, H29. Serial Numbers:  H140927 H191045 H294986 H295004 H295021 H295036 H140929 H191048 H294988 H295010 H295025 H295042 H140932 H191049 H294989 H295012 H295031 H295047 H140934 H191050 H294999 H295013 H295032 H295051 H191035 H272973 H295001 H295014 H295033 H295058 H191044 H294979 H295002 H295015 H295034 H295068 
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Michael Pignataro
650-424-5825
Manufacturer Reason
for Recall		 Some drive stand bolts may fail to meet mechanical specifications.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Varian Medical Systems, Inc sent a "Urgent Medical Device Correction Urgent Field Safety Notice" letter dated May 13, 2011 to all affected customers. The letter included a description of product, problem and recommendations. This includes performing daily QA to detect isocenter shift and the use of independent patient position system. Customers are advised to discontinue its use if a shift is detected and to contact Varian Medical Systems for a replacement stand bolts and adjustment if necessary. For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265)
Quantity in Commerce 36
Distribution Worldwide distribution: (USA) Nationwide including the states of PA. NJ, NY, MA, VA, TX, KS, FL, OH, SC, MN, CA, TN and NV; and the countries of Canada, Colombia, France, Italy, Japan, Netherlands 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 = VARIAN MEDICAL SYSTEMS
510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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