Class 2 Device Recall Varian brand High Energy Linear Accelerator

• Date Initiated by Firm: November 28, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated on June 02, 2015
• Recall Number: Z-0692-2012
• Recall Event ID: 60659
• 510(K)Number: K926321 K112839
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Varian High Energy Linear Accelerator, C-Series Clinac, Reference/FSCA Identifier: CP-06611; Models Numbers: 600C, 600CD, 6EX, DBX, 2100C, 2100CD, 2300CD, 21EX, 23EX, DMX, DHX versions 2.x through 6.x; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. ; ; The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
• Code Information: ,H140002 ,H140087 ,H180135 , H180273 ,H180463 ,H180554 , H180623 ,H180685 ,H180747 , H180809 ,H180868 ,H181026 , H181085, H140003 ,H140089 , H180143 , H180274 ,H180466 ,H180555 ,H180624 ,H180686 ,H180748 ,H180810 ,H180869 ,H181027 ,H181086 ,H140004 ,H140091 ,H180144 ,H180275 ,H180467 ,H180556 ,H180625 ,H180687 ,H180749 ,H180811 ,H180870 ,H181028 ,H181087 ,H140005 ,H140093 ,H180148 ,H180283 ,H180469 ,H180559 ,H180626 ,H180688 ,H180750 ,H180812 ,H180871 ,H181029 ,H181088 ,H140006 ,H140094 ,H180157 ,H180287 ,H180470 ,H180560 ,H180627 ,H180689 ,H180751 ,H180813 ,H180872 ,H181030 ,H181089 ,H140007 ,H140095 ,H180159 ,H180290 ,H180471 ,H180561 ,H180628 ,H180690 ,H180752 ,H180814 ,H180873 ,H181031 ,H181090 ,H140008 ,H140099 ,H180161 ,H180291 ,H180472 ,H180562 ,H180629 ,H180691 ,H180753 ,H180815 ,H180874 ,H181032 ,H181091 ,H140009 ,H140100 ,H180166 ,H180292 ,H180473 ,H180564 ,H180630 ,H180692 ,H180754 ,H180816 ,H180875 ,H181033 ,H181092 ,H140010 ,H140102 ,H180167 ,H180293 ,H180474 ,H180566 ,H180631 ,H180694 ,H180755 ,H180817 ,H180876 ,H181034 ,H181093 ,H140012 ,H140103 ,H180171 ,H180294 ,H180475 ,H180568 ,H180632 ,H180695 ,H180756 ,H180818 ,H180877 ,H181035 ,H181094 ,H140014 ,H140105 ,H180175 ,H180295 ,H180476 ,H180569 ,H180633 ,H180696 ,H180757 ,H180819 ,H180878 ,H181036 ,H181095 ,H140015 ,H140106 ,H180178 ,H180296 ,H180477 ,H180570 ,H180634 ,H180697 ,H180758 ,H180820 ,H180879 ,H181037 ,H181096 ,H140016 ,H140108 ,H180179 ,H180298 ,H180478 ,H180572 ,H180635 ,H180698 ,H180759 ,H180821 ,H180880 ,H181038 ,H181097 ,H140017 ,H140110 ,H180181 ,H180307 ,H180480 ,H180573 ,H180636 ,H180699 ,H180760 ,H180822 ,H180881 ,H181039 ,H181098 ,H140019 ,H140112 ,H180182 ,H180309 ,H180482 ,H180574 ,H180637 ,H180700 ,H180761 ,H180823 ,H180882 ,H181040 ,H181099 ,H140021 ,H140120 ,H180186 ,H180311 ,H180484 ,H180575 ,H180638 ,H180701 ,H180762 ,H180824 ,H180883 ,H181041 ,H181100 ,H140022 ,H140123 ,H180192 ,H180312 ,H180485 ,H180576 ,H180639 ,H180702 ,H180763 ,H180825 ,H180884 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,H180588 ,H180649 ,H180711 ,H180772 ,H180834 ,H180895 ,H181051 ,H181110 ,H140037 ,H180016 ,H180214 ,H180406 ,H180501 ,H180589 ,H180650 ,H180713 ,H180773 ,H180835 ,H180896 ,H181052 ,H181111 ,H140040 ,H180019 ,H180215 ,H180407 ,H180507 ,H180590 ,H180651 ,H180714 ,H180774 ,H180836 ,H180897 ,H181053 ,H181112 ,H140041 ,H180025 ,H180217 ,H180409 ,H180509 ,H180591 ,H180652 ,H180715 ,H180775 ,H180837 ,H180898 ,H181055 ,H181113 ,H140042 ,H180028 ,H180218 ,H180411 ,H180510 ,H180592 ,H180653 ,H180716 ,H180776 ,H180838 ,H180899 ,H181056 ,H181114 ,H140044 ,H180040 ,H180220 ,H180412 ,H180511 ,H180593 ,H180654 ,H180717 ,H180777 ,H180839 ,H180901 ,H181057 ,H181115 ,H140049 ,H180043 ,H180221 ,H180414 ,H180514 ,H180594 ,H180655 ,H180718 ,H180778 ,H180840 ,H180907 ,H181058 ,H181116 ,H140050 ,H180044 ,H180222 ,H180417 ,H180515 ,H180595 ,H180656 ,H180719 ,H180779 ,H180841 ,H181000 ,H181059 ,H181117 ,H140051 ,H180048 ,H180225 ,H180420 ,H180517 ,H180596 ,H180657 ,H180720 ,H180780 ,H180842 ,H181001 ,H181060 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,H180667 ,H180730 ,H180791 ,H180852 ,H181010 ,H181069 ,H181128 ,H140063 ,H180080 ,H180242 ,H180442 ,H180533 ,H180606 ,H180669 ,H180731 ,H180792 ,H180853 ,H181011 ,H181070 ,H181129 ,H140064 ,H180083 ,H180243 ,H180444 ,H180534 ,H180607 ,H180670 ,H180733 ,H180793 ,H180854 ,H181012 ,H181071 ,H181130 ,H140065 ,H180087 ,H180245 ,H180445 ,H180535 ,H180608 ,H180671 ,H180734 ,H180794 ,H180855 ,H181013 ,H181072 ,H181132 ,H140066 ,H180098 ,H180249 ,H180446 ,H180536 ,H180610 ,H180672 ,H180735 ,H180796 ,H180856 ,H181014 ,H181073 ,H181133 ,H140068 ,H180099 ,H180250 ,H180447 ,H180538 ,H180611 ,H180673 ,H180736 ,H180798 ,H180857 ,H181015 ,H181074 ,H181134 ,H140069 ,H180102 ,H180254 ,H180449 ,H180539 ,H180612 ,H180674 ,H180737 ,H180799 ,H180858 ,H181016 ,H181075 ,H181135 ,H140072 ,H180103 ,H180255 ,H180450 ,H180541 ,H180614 ,H180675 ,H180738 ,H180800 ,H180859 ,H181017 ,H181076 ,H181136 ,H140074 ,H180104 ,H180256 ,H180451 ,H180542 ,H180615 ,H180676 ,H180739 ,H180801 ,H180860 ,H181018 ,H181077 ,H181137 ,H140075 ,H180107 ,H180257 ,H180453 ,H180543 ,H180616 ,H180678 ,H180740 ,H180802 ,H180861 ,H181019 ,H181078 ,H181138 ,H140080 ,H180115 ,H180258 ,H180454 ,H180544 ,H180617 ,H180679 ,H180741 ,H180803 ,H180862 ,H181020 ,H181079 ,H181139 ,H140082 ,H180116 ,H180260 ,H180456 ,H180548 ,H180618 ,H180680 ,H180742 ,H180804 ,H180863 ,H181021 ,H181080 ,H181140 ,H140083 ,H180117 ,H180262 ,H180457 ,H180549 ,H180619 ,H180681 ,H180743 ,H180805 ,H180864 ,H181022 ,H181081 ,H181141 ,H140084 ,H180122 ,H180268 ,H180459 ,H180550 ,H180620 ,H180682 ,H180744 ,H180806 ,H180865 ,H181023 ,H181082 ,H181142 ,H140085 ,H180124 ,H180271 ,H180460 ,H180551 ,H180621 ,H180683 ,H180745 ,H180807 ,H180866 ,H181024 ,H181083 ,H181143 ,H140086 ,H180129 ,H180272 ,H180462 ,H180553 ,H180622 ,H180684 ,H180746 ,H180808 ,H180867 ,H181025 ,H181084 ,H181145 ,H181146 ,H181210 ,H270260 ,H270447 ,H270634 ,H270783 ,H270894 ,H271101 ,H271225 ,H271320 ,H271409 ,H271499 ,H271575 ,H181147 ,H181211 ,H270261 ,H270451 ,H270635 ,H270785 ,H270895 ,H271102 ,H271228 ,H271322 ,H271410 ,H271500 ,H271576 ,H181148 ,H181212 ,H270267 ,H270452 ,H270639 ,H270787 ,H270897 ,H271103 ,H271229 ,H271325 ,H271411 ,H271501 ,H271577 ,H181149 ,H181214 ,H270271 ,H270454 ,H270641 ,H270789 ,H270898 ,H271104 ,H271231 ,H271327 ,H271412 ,H271503 ,H271578 ,H181150 ,H181215 ,H270273 ,H270455 ,H270644 ,H270793 ,H270899 ,H271107 ,H271233 ,H271328 ,H271415 ,H271504 ,H271580 ,H181151 ,H181218 ,H270277 ,H270458 ,H270645 ,H270796 ,H271000 ,H271108 ,H271234 ,H271329 ,H271416 ,H271505 ,H271581 ,H181152 ,H181220 ,H270280 ,H270461 ,H270646 ,H270800 ,H271002 ,H271109 ,H271235 ,H271330 ,H271417 ,H271506 ,H271583 ,H181153 ,H181222 ,H270281 ,H270462 ,H270647 ,H270801 ,H271004 ,H271110 ,H271236 ,H271331 ,H271419 ,H271508 ,H271584 ,H181154 ,H181223 ,H270282 ,H270464 ,H270649 ,H270803 ,H271005 ,H271111 ,H271238 ,H271332 ,H271421 ,H271509 ,H271586 ,H181155 ,H181224 ,H270285 ,H270466 ,H270651 ,H270804 ,H271009 ,H271113 ,H271239 ,H271333 ,H271422 ,H271510 ,H271589 ,H181156 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• Recalling Firm/ Manufacturer: Varian Medical Systems, Inc. Oncology Systems; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: Peter J. Coronado; 650-424-5731
• Manufacturer Reason for Recall: An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator.
• FDA Determined Cause: Device Design
• Action: Varian Medical Systems sent an Urgent Medical Device Correction - Urgent Field Safety Notice dated November 28, 2011 ***Expanded to include product #2 on December 16, 2011***, to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to establish a comprehensive quality assurance program before beginning treatments for the day, quality assurance tests must be performed. Additionally, any discrepancies in imaging field sizes vs planned field size should be brought to the attention of the medical physicist for investigation before treatment continues. Customers were asked to complete the attached Proof of Notification or Receipt Verification Card once they have read the document and return it to Varian Medical Systems. For question regarding this recall: USA and Canada 1-888-827-4265 Europe +41 41 749 8844
• Quantity in Commerce: 6158 units total
• 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