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U.S. Department of Health and Human Services

Class 2 Device Recall Clinac

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  Class 2 Device Recall Clinac see related information
Date Initiated by Firm May 02, 2007
Date Posted July 12, 2007
Recall Status1 Terminated 3 on November 27, 2010
Recall Number Z-1074-2007
Recall Event ID 38048
510(K)Number K913119  K862645  
Product Classification Medical Linear Accelerator - Product Code IYE
Product Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &C/D
Code Information Serial numbers: H271877 H271036 H290175 H290157 H290215 H180257 H180534 H271708 H180236 H180534 H271708 H271947 H271096 H290541 H271321 H180811 H290305 H272102 H180044 H271340 H271067 H270755 H271043 H271671 H270518 H270864 H271228 H271645 H271118 H271603 H270704 H180230 H290272 H271264 H270471 H272116 H271531 H271233 H270486 H271062 H271091 H271344 H180449 H271371 H180410 H270237 H290227 H290218 H180562 H271758 H270472 H271830 H180484 H270763 H270733 H271930 H290149 H271552 H270819 H270628 H271079 H271673 H270546 H290348 H271871 H273089 H271070 H271649 H180510 H290203 H290228 H290189 H290219 H271521 H271150 H180440 H270533 H180284 H271154 H180542 H270429 H180239 H290300 H271133 
Recalling Firm/
Manufacturer		 Varian Medical Systems Inc
911 Hansen Way
Palo Alto CA 94304
For Additional Information Contact
650-424-5731
Manufacturer Reason
for Recall		 The wedge tray may slip out of the Clinac interface mount during gantry rotation.
FDA Determined
Cause 2		 Process control
Action The firm sent out a Product Notification Letter on 5/2/07 to customers who have ordered this guide block through a Varian Service Center. A Varian Field Engineer will visually inspect guide blocks at-site that have been installed from Service stock for all affected customers, and replace if necessary.
Quantity in Commerce 209 units
Distribution Product was distributed and manufactured between 1999 and 2006. Distributed worldwide, including USA, Ecuador, Columbia, Taiwan, Austrailia, Austria, Brazil, Canada, Chile, China, Finland, France, Germany, India, Italy, Japan, New Zealand, Poland, Portugal, Serbia and Montenegro, Singapore, Spain, Switzerland, UAE, and UK.
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.
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