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U.S. Department of Health and Human Services

Class 2 Device Recall Varian brand C Series Clinics

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  Class 2 Device Recall Varian brand C Series Clinics see related information
Date Initiated by Firm December 01, 2009
Date Posted January 31, 2011
Recall Status1 Terminated 3 on March 14, 2012
Recall Number Z-1001-2011
Recall Event ID 56354
510(K)Number K092871  K072916  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Varian brand C Series Clinic¿s (Includes Trilogy, and Novalis Tx), Model Numbers: H14, H26, H27, H29, Distributed by and/or Manufactured by: Varian Medical Systems Inc., Palo Alto, CA

The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.

Intended use: The Trilogy Mx" System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

7/9/2013 - UPDATE: Determined that the correction only applied to C3 users, not C1 and C2 users.
Code Information H140001 ,H140042 ,H140083 ,H140124 ,H140210 ,H140709 ,H140749 ,H140789 ,H140832 ,H260940 H140002 ,H140043 ,H140084 ,H140125 ,H140211 ,H140710 ,H140750 ,H140790 ,H140833 ,H260942 H140003 ,H140044 ,H140085 ,H140126 ,H140212 ,H140711 ,H140751 ,H140791 ,H140834 ,H260944 H140004 ,H140045 ,H140086 ,H140127 ,H140213 ,H140712 ,H140752 ,H140792 ,H140835 ,H260946 H140005 ,H140046 ,H140087 ,H140128 ,H140214 ,H140713 ,H140753 ,H140793 ,H140836 ,H260947 H140006 ,H140047 ,H140088 ,H140129 ,H140215 ,H140714 ,H140754 ,H140794 ,H140837 ,H260948 H140007 ,H140048 ,H140089 ,H140130 ,H140216 ,H140715 ,H140755 ,H140795 ,H140838 ,H260949 H140008 ,H140049 ,H140090 ,H140131 ,H140217 ,H140716 ,H140756 ,H140796 ,H140839 ,H260950 H140009 ,H140050 ,H140091 ,H140132 ,H140218 ,H140717 ,H140757 ,H140797 ,H140840 ,H260951 H140010 ,H140051 ,H140092 ,H140133 ,H140219 ,H140718 ,H140758 ,H140798 ,H140841 ,H260952 H140011 ,H140052 ,H140093 ,H140134 ,H140220 ,H140719 ,H140759 ,H140799 ,H140842 ,H260953 H140012 ,H140053 ,H140094 ,H140135 ,H140221 ,H140720 ,H140760 ,H140800 ,H140843 ,H270001 H140014 ,H140054 ,H140095 ,H140136 ,H140222 ,H140721 ,H140761 ,H140801 ,H140846 ,H270004 H140015 ,H140055 ,H140096 ,H140137 ,H140223 ,H140722 ,H140762 ,H140802 ,H140848 ,H270006 H140016 ,H140056 ,H140097 ,H140138 ,H140224 ,H140723 ,H140763 ,H140804 ,H149999 ,H270009 H140017 ,H140057 ,H140098 ,H140139 ,H140225 ,H140724 ,H140764 ,H140805 ,H260901 ,H270010 H140018 ,H140058 ,H140099 ,H140140 ,H140226 ,H140725 ,H140765 ,H140806 ,H260902 ,H270012 H140019 ,H140059 ,H140100 ,H140141 ,H140227 ,H140726 ,H140766 ,H140807 ,H260905 ,H270017 H140020 ,H140060 ,H140101 ,H140142 ,H140228 ,H140727 ,H140767 ,H140808 ,H260909 ,H270021 H140021 ,H140061 ,H140102 ,H140143 ,H140229 ,H140728 ,H140768 ,H140809 ,H260910 ,H270022 H140022 ,H140062 ,H140103 ,H140144 ,H140230 ,H140729 ,H140769 ,H140810 ,H260913 ,H270026 H140023 ,H140063 ,H140105 ,H140145 ,H140231 ,H140730 ,H140770 ,H140811 ,H260915 ,H270027 H140024 ,H140064 ,H140106 ,H140146 ,H140232 ,H140731 ,H140771 ,H140812 ,H260916 ,H270029 H140025 ,H140065 ,H140107 ,H140147 ,H140233 ,H140732 ,H140772 ,H140813 ,H260917 ,H270030 H140026 ,H140066 ,H140108 ,H140148 ,H140234 ,H140733 ,H140773 ,H140814 ,H260918 ,H270031 H140027 ,H140067 ,H140109 ,H140149 ,H140235 ,H140734 ,H140774 ,H140815 ,H260919 ,H270038 H140028 ,H140068 ,H140110 ,H140150 ,H140236 ,H140735 ,H140775 ,H140817 ,H260920 ,H270045 H140029 ,H140069 ,H140111 ,H140151 ,H140237 ,H140736 ,H140776 ,H140818 ,H260922 ,H270047 H140030 ,H140070 ,H140112 ,H140152 ,H140238 ,H140737 ,H140777 ,H140819 ,H260923 ,H270050 H140031 ,H140071 ,H140113 ,H140153 ,H140239 ,H140738 ,H140778 ,H140820 ,H260924 ,H270060 H140032 ,H140072 ,H140114 ,H140154 ,H140240 ,H140739 ,H140779 ,H140821 ,H260926 ,H270068 H140033 ,H140073 ,H140115 ,H140201 ,H140700 ,H140740 ,H140780 ,H140822 ,H260928 ,H270072 H140034 ,H140074 ,H140116 ,H140202 ,H140701 ,H140741 ,H140781 ,H140823 ,H260930 ,H270073 H140035 ,H140075 ,H140117 ,H140203 ,H140702 ,H140742 ,H140782 ,H140824 ,H260931 ,H270074 H140036 ,H140076 ,H140118 ,H140204 ,H140703 ,H140743 ,H140783 ,H140825 ,H260932 ,H270075 H140037 ,H140077 ,H140119 ,H140205 ,H140704 ,H140744 ,H140784 ,H140826 ,H260933 ,H270079 H140038 ,H140078 ,H140120 ,H140206 ,H140705 ,H140745 ,H140785 ,H140827 ,H260935 ,H270084 H140039 ,H140079 ,H140121 ,H140207 ,H140706 ,H140746 ,H140786 ,H140828 ,H260936 ,H270088 H140040 ,H140080 ,H140122 ,H140208 ,H140707 ,H140747 ,H140787 ,H140830 ,H260938 ,H270094 H140041 ,H140082 ,H140123 ,H140209 ,H140708 ,H140748 ,H140788 ,H140831 ,H260939 ,H270096     H270101 ,H270256 ,H270344 ,H270421 ,H270486 ,H270601 ,H270664 ,H270728 ,H270790 ,H270847 H270103 ,H270260 ,H270345 ,H270425 ,H270487 ,H270602 ,H270665 ,H270729 ,H270791 ,H270848 H270106 ,H270261 ,H270346 ,H270426 ,H270489 ,H270603 ,H270667 ,H270730 ,H270792 ,H270849 H270107 ,H270264 ,H270349 ,H270427 ,H270490 ,H270604 ,H270669 ,H270731 ,H270793 ,H270850 H270108 ,H270267 ,H270351 ,H270428 ,H270495 ,H270605 ,H270670 ,H270732 ,H270794 ,H270852 H270109 ,H270270 ,H270353 ,H270430 ,H270496 ,H270606 ,H270671 ,H270733 ,H270795 ,H270854 H270110 ,H270271 ,H270355 ,H270431 ,H270498 ,H270607 ,H270672 ,H270735 ,H270796 ,H270855 H270111 ,H270273 ,H270356 ,H270433 ,H270499 ,H270613 ,H270673 ,H270736 ,H270797 ,H270856 H270113 ,H270274 ,H270357 ,H270435 ,H270500 ,H270615 ,H270674 ,H270737 ,H270799 ,H270857 H270116 ,H270277 ,H270360 ,H270436 ,H270501 ,H270616 ,H270675 ,H270739 ,H270800 ,H270858 H270118 ,H270280 ,H270361 ,H270437 ,H270502 ,H270617 ,H270680 ,H270740 ,H270801 ,H270859 H270123 ,H270281 ,H270364 ,H270438 ,H270503 ,H270618 ,H270681 ,H270741 ,H270803 ,H270861 H270126 ,H270282 ,H270365 ,H270439 ,H270504 ,H270622 ,H270682 ,H270743 ,H270804 ,H270862 H270128 ,H270284 ,H270370 ,H270443 ,H270505 ,H270623 ,H270684 ,H270744 ,H270805 ,H270863 H270134 ,H270285 ,H270371 ,H270445 ,H270506 ,H270624 ,H270685 ,H270745 ,H270806 ,H270864 H270136 ,H270288 ,H270373 ,H270446 ,H270507 ,H270625 ,H270686 ,H270746 ,H270808 ,H270865 H270138 ,H270290 ,H270375 ,H270447 ,H270508 ,H270626 ,H270687 ,H270749 ,H270809 ,H270866 H270141 ,H270291 ,H270377 ,H270448 ,H270509 ,H270627 ,H270689 ,H270751 ,H270810 ,H270867 H270143 ,H270293 ,H270378 ,H270449 ,H270510 ,H270628 ,H270690 ,H270752 ,H270812 ,H270868 H270144 ,H270297 ,H270379 ,H270450 ,H270511 ,H270629 ,H270692 ,H270754 ,H270813 ,H270869 H270201 ,H270299 ,H270380 ,H270451 ,H270512 ,H270630 ,H270693 ,H270755 ,H270814 ,H270870 H270209 ,H270300 ,H270381 ,H270452 ,H270513 ,H270631 ,H270695 ,H270757 ,H270817 ,H270871 H270211 ,H270301 ,H270384 ,H270454 ,H270514 ,H270632 ,H270697 ,H270759 ,H270819 ,H270872 H270214 ,H270302 ,H270385 ,H270455 ,H270516 ,H270633 ,H270698 ,H270760 ,H270820 ,H270873 H270215 ,H270303 ,H270386 ,H270457 ,H270518 ,H270634 ,H270699 ,H270761 ,H270821 ,H270874 H270216 ,H270305 ,H270387 ,H270458 ,H270520 ,H270635 ,H270700 ,H270762 ,H270822 ,H270875 H270219 ,H270308 ,H270391 ,H270459 ,H270522 ,H270637 ,H270702 ,H270763 ,H270823 ,H270877 H270226 ,H270309 ,H270392 ,H270461 ,H270523 ,H270639 ,H270703 ,H270766 ,H270825 ,H270878 H270227 ,H270310 ,H270395 ,H270462 ,H270524 ,H270641 ,H270704 ,H270767 ,H270826 ,H270879 H270228 ,H270311 ,H270396 ,H270463 ,H270525 ,H270642 ,H270705 ,H270768 ,H270827 ,H270880 H270229 ,H270312 ,H270397 ,H270464 ,H270526 ,H270643 ,H270708 ,H270769 ,H270828 ,H270881 H270230 ,H270314 ,H270398 ,H270466 ,H270529 ,H270644 ,H270709 ,H270770 ,H270829 ,H270882 H270232 ,H270316 ,H270399 ,H270468 ,H270530 ,H270645 ,H270710 ,H270775 ,H270830 ,H270883 H270233 ,H270320 ,H270400 ,H270470 ,H270532 ,H270646 ,H270712 ,H270776 ,H270831 ,H270884 H270235 ,H270321 ,H270401 ,H270471 ,H270533 ,H270647 ,H270713 ,H270777 ,H270832 ,H270885 H270237 ,H270323 ,H270404 ,H270472 ,H270534 ,H270648 ,H270714 ,H270778 ,H270833 ,H270886 H270240 ,H270324 ,H270406 ,H270473 ,H270535 ,H270649 ,H270715 ,H270779 ,H270835 ,H270887 H270241 ,H270328 ,H270407 ,H270474 ,H270538 ,H270651 ,H270716 ,H270780 ,H270836 ,H270888 H270242 ,H270329 ,H270408 ,H270475 ,H270539 ,H270652 ,H270717 ,H270781 ,H270837 ,H270889 H270244 ,H270332 ,H270409 ,H270476 ,H270540 ,H270653 ,H270718 ,H270782 ,H270838 ,H270890 H270245 ,H270335 ,H270410 ,H270477 ,H270542 ,H270654 ,H270719 ,H270783 ,H270840 ,H270891 H270248 ,H270336 ,H270412 ,H270479 ,H270544 ,H270656 ,H270721 ,H270784 ,H270841 ,H270892 H270251 ,H270337 ,H270414 ,H270480 ,H270545 ,H270658 ,H270722 ,H270785 ,H270842 ,H270893 H270252 ,H270338 ,H270416 ,H270482 ,H270546 ,H270660 ,H270723 ,H270786 ,H270843 ,H270894 H270253 ,H270341 ,H270418 ,H270483 ,H270547 ,H270661 ,H270725 ,H270787 ,H270844 ,H270895 H270254 ,H270342 ,H270419 ,H270484 ,H270550 ,H270662 ,H270726 ,H270788 ,H270845 ,H270896 H270255 ,H270343 ,H270420 ,H270485 ,H270600 ,H270663 ,H270727 ,H270789 ,H270846 ,H270897     H270898 ,H271050 ,H271103 ,H271152 ,H271205 ,H271256 ,H271305 ,H271355 ,H271406 ,H271454 H270899 ,H271051 ,H271104 ,H271153 ,H271206 ,H271257 ,H271306 ,H271356 ,H271407 ,H271455 H271000 ,H271052 ,H271105 ,H271154 ,H271207 ,H271258 ,H271307 ,H271357 ,H271408 ,H271456 H271001 ,H271055 ,H271106 ,H271155 ,H271208 ,H271259 ,H271308 ,H271358 ,H271409 ,H271457 H271002 ,H271056 ,H271107 ,H271157 ,H271209 ,H271260 ,H271309 ,H271359 ,H271410 ,H271458 H271003 ,H271057 ,H271108 ,H271159 ,H271210 ,H271261 ,H271310 ,H271360 ,H271411 ,H271459 H271004 ,H271058 ,H271109 ,H271160 ,H271211 ,H271263 ,H271311 ,H271361 ,H271412 ,H271460 H271005 ,H271059 ,H271110 ,H271161 ,H271212 ,H271264 ,H271312 ,H271362 ,H271413 ,H271461 H271006 ,H271060 ,H271111 ,H271162 ,H271213 ,H271265 ,H271314 ,H271363 ,H271414 ,H271462 H271007 ,H271061 ,H271112 ,H271163 ,H271214 ,H271266 ,H271315 ,H271364 ,H271415 ,H271463 H271008 ,H271062 ,H271113 ,H271164 ,H271215 ,H271267 ,H271316 ,H271365 ,H271416 ,H271464 H271009 ,H271063 ,H271114 ,H271165 ,H271216 ,H271268 ,H271317 ,H271367 ,H271417 ,H271465 H271010 ,H271065 ,H271115 ,H271166 ,H271217 ,H271269 ,H271318 ,H271369 ,H271418 ,H271466 H271011 ,H271066 ,H271116 ,H271167 ,H271218 ,H271271 ,H271319 ,H271370 ,H271419 ,H271467 H271013 ,H271067 ,H271117 ,H271168 ,H271219 ,H271272 ,H271320 ,H271371 ,H271420 ,H271468 H271014 ,H271068 ,H271118 ,H271169 ,H271220 ,H271273 ,H271321 ,H271372 ,H271421 ,H271469 H271015 ,H271070 ,H271119 ,H271170 ,H271222 ,H271274 ,H271322 ,H271373 ,H271422 ,H271470 H271016 ,H271071 ,H271120 ,H271171 ,H271223 ,H271275 ,H271323 ,H271374 ,H271423 ,H271471 H271017 ,H271072 ,H271121 ,H271172 ,H271224 ,H271276 ,H271324 ,H271375 ,H271424 ,H271472 H271018 ,H271073 ,H271122 ,H271174 ,H271225 ,H271277 ,H271325 ,H271376 ,H271425 ,H271473 H271019 ,H271075 ,H271123 ,H271175 ,H271226 ,H271278 ,H271327 ,H271377 ,H271426 ,H271474 H271020 ,H271076 ,H271124 ,H271176 ,H271227 ,H271279 ,H271328 ,H271378 ,H271427 ,H271475 H271021 ,H271077 ,H271125 ,H271177 ,H271228 ,H271280 ,H271329 ,H271379 ,H271429 ,H271476 H271022 ,H271078 ,H271126 ,H271178 ,H271229 ,H271281 ,H271330 ,H271380 ,H271430 ,H271477 H271023 ,H271079 ,H271127 ,H271179 ,H271230 ,H271282 ,H271331 ,H271381 ,H271431 ,H271478 H271024 ,H271080 ,H271128 ,H271182 ,H271231 ,H271283 ,H271332 ,H271382 ,H271432 ,H271479 H271025 ,H271082 ,H271130 ,H271183 ,H271232 ,H271284 ,H271333 ,H271383 ,H271433 ,H271480 H271026 ,H271083 ,H271131 ,H271184 ,H271233 ,H271285 ,H271334 ,H271384 ,H271434 ,H271481 H271027 ,H271084 ,H271132 ,H271185 ,H271234 ,H271286 ,H271335 ,H271385 ,H271435 ,H271482 H271029 ,H271085 ,H271133 ,H271186 ,H271235 ,H271287 ,H271336 ,H271386 ,H271436 ,H271483 H271031 ,H271086 ,H271135 ,H271187 ,H271236 ,H271288 ,H271337 ,H271387 ,H271437 ,H271484 H271032 ,H271087 ,H271136 ,H271188 ,H271237 ,H271289 ,H271338 ,H271388 ,H271438 ,H271485 H271033 ,H271088 ,H271137 ,H271189 ,H271238 ,H271290 ,H271339 ,H271389 ,H271439 ,H271486 H271034 ,H271089 ,H271138 ,H271190 ,H271239 ,H271291 ,H271340 ,H271390 ,H271440 ,H271487 H271035 ,H271090 ,H271139 ,H271191 ,H271241 ,H271292 ,H271341 ,H271391 ,H271441 ,H271488 H271036 ,H271091 ,H271140 ,H271192 ,H271242 ,H271293 ,H271342 ,H271392 ,H271442 ,H271489 H271037 ,H271092 ,H271141 ,H271193 ,H271243 ,H271294 ,H271343 ,H271393 ,H271443 ,H271490 H271038 ,H271093 ,H271142 ,H271194 ,H271244 ,H271295 ,H271344 ,H271394 ,H271444 ,H271491 H271039 ,H271094 ,H271143 ,H271195 ,H271245 ,H271296 ,H271345 ,H271395 ,H271445 ,H271492 H271040 ,H271095 ,H271144 ,H271196 ,H271247 ,H271297 ,H271346 ,H271397 ,H271446 ,H271493 H271041 ,H271096 ,H271145 ,H271197 ,H271248 ,H271298 ,H271347 ,H271398 ,H271447 ,H271494 H271042 ,H271097 ,H271146 ,H271198 ,H271249 ,H271299 ,H271348 ,H271399 ,H271448 ,H271495 H271043 ,H271098 ,H271147 ,H271199 ,H271250 ,H271300 ,H271349 ,H271400 ,H271449 ,H271496 H271044 ,H271099 ,H271148 ,H271200 ,H271251 ,H271301 ,H271350 ,H271401 ,H271450 ,H271497 H271046 ,H271100 ,H271149 ,H271201 ,H271252 ,H271302 ,H271351 ,H271402 ,H271451 ,H271498 H271047 ,H271101 ,H271150 ,H271202 ,H271253 ,H271303 ,H271353 ,H271403 ,H271452 ,H271499 H271048 ,H271102 ,H271151 ,H271204 ,H271254 ,H271304 ,H271354 ,H271404 ,H271453 ,H271500     H271501 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,H291078 ,H290114 ,H290182 ,H290230 ,H290280 ,H290330 ,H290377 ,H290500 ,H290547 ,H291032 ,H291079 ,H290116 ,H290183 ,H290231 ,H290281 ,H290331 ,H290378 ,H290501 ,H290548 ,H291033 ,H291080 ,H290117 ,H290185 ,H290232 ,H290282 ,H290332 ,H290379 ,H290502 ,H290549 ,H291034 ,H291081 ,H290118 ,H290186 ,H290233 ,H290283 ,H290333 ,H290380 ,H290503 ,H290550 ,H291035 ,H291082 ,H290119 ,H290187 ,H290234 ,H290284 ,H290334 ,H290381 ,H290504 ,H290551 ,H291036 ,H291083 ,H290121 ,H290188 ,H290236 ,H290285 ,H290335 ,H290382 ,H290505 ,H290552 ,H291037 ,H291084 ,H290122 ,H290189 ,H290237 ,H290286 ,H290336 ,H290383 ,H290506 ,H290553 ,H291038 ,H291085 ,H290123 ,H290190 ,H290238 ,H290287 ,H290337 ,H290384 ,H290507 ,H290554 ,H291039 ,H291086 ,H290125 ,H290191 ,H290239 ,H290288 ,H290338 ,H290385 ,H290508 ,H290555 ,H291040 ,H291087 ,H290128 ,H290192 ,H290240 ,H290289 ,H290339 ,H290386 ,H290509 ,H290556 ,H291041 ,H291088 ,H290130 ,H290193 ,H290241 ,H290290 ,H290340 ,H290387 ,H290510 ,H290557 ,H291042 ,H291089 ,H290131 ,H290194 ,H290242 ,H290291 ,H290341 ,H290388 ,H290511 ,H290558 ,H291043 ,H291090 ,H290132 ,H290195 ,H290243 ,H290292 ,H290342 ,H290389 ,H290512 ,H290559 ,H291044 ,H291091 ,H290134 ,H290196 ,H290244 ,H290293 ,H290343 ,H290390 ,H290513 ,H290560 ,H291045 ,H291092 ,H290135 ,H290197 ,H290245 ,H290294 ,H290344 ,H290391 ,H290514 ,H290561 ,H291046 ,H291093 ,H290137 ,H290198 ,H290246 ,H290295 ,H290345 ,H290392 ,H290515 ,H290600 ,H291047 ,H291094 ,H290138 ,H290199 ,H290247 ,H290296 ,H290346 ,H290393 ,H290516 ,H291001 ,H291048 ,H291095 ,H290139 ,H290200 ,H290248 ,H290297 ,H290347 ,H290394 ,H290517 ,H291002 ,H291049 ,H291096 ,H290141 ,H290201 ,H290249 ,H290299 ,H290348 ,H290395 ,H290518 ,H291003 ,H291050 ,H291097 ,H290142 ,H290202 ,H290250 ,H290301 ,H290349 ,H290396 ,H290519 ,H291004 ,H291051 ,H291098 ,H290143 ,H290203 ,H290251 ,H290302 ,H290350 ,H290397 ,H290520 ,H291005 ,H291052 ,H291099 ,H290144 ,H290204 ,H290253 ,H290304 ,H290351 ,H290398 ,H290521 ,H291006 ,H291053 ,H291100 ,H290145 ,H290205 ,H290254 ,H290305 ,H290352 ,H290399 ,H290522 ,H291007 ,H291054 ,H291101 ,H290146 ,H290206 ,H290255 ,H290306 ,H290353 ,H290400 ,H290523 ,H291008 ,H291055 ,H291102 ,H290148 ,H290207 ,H290256 ,H290307 ,H290354 ,H290401 ,H290524 ,H291009 ,H291056 ,H291103 ,H290149 ,H290208 ,H290257 ,H290308 ,H290355 ,H290402 ,H290525 ,H291010 ,H291057 ,H291104 ,H290151 ,H290209 ,H290258 ,H290309 ,H290356 ,H290403 ,H290526 ,H291011 ,H291058 ,H291105 ,H290152 ,H290210 ,H290259 ,H290310 ,H290357 ,H290404 ,H290527 ,H291012 ,H291059 ,H291106 ,H290154 ,H290211 ,H290260 ,H290311 ,H290358 ,H290405 ,H290528 ,H291013 ,H291060 ,H291107 ,H290155 ,H290212 ,H290261 ,H290312 ,H290359 ,H290406 ,H290529 ,H291014 ,H291061 ,H291108 ,H290156 ,H290213 ,H290262 ,H290313 ,H290360 ,H290407 ,H290530 ,H291015 ,H291062 ,H291109 ,H290157 ,H290214 ,H290263 ,H290314 ,H290361 ,H290408 ,H290531 ,H291016 ,H291063 ,H291111 ,H290158 ,H290215 ,H290264 ,H290315 ,H290362 ,H290409 ,H290532 ,H291017 ,H291064 ,H291112 ,H290160 ,H290216 ,H290265 ,H290316 ,H290363 ,H290410 ,H290533 ,H291018 ,H291065 ,H291113 ,H290161 ,H290217 ,H290266 ,H290317 ,H290364 ,H290411 ,H290534 ,H291019 ,H291066 ,H291114 ,H290162 ,H290218 ,H290267 ,H290318 ,H290365 ,H290412 ,H290535 ,H291020 ,H291067 ,H291115 ,H290164 ,H290219 ,H290268 ,H290319 ,H290366 ,H290413 ,H290536 ,H291021 ,H291068 ,H291116 ,H290165 ,H290220 ,H290269 ,H290320 ,H290367 ,H290414 ,H290537 ,H291022 ,H291069 ,H291117 ,H290166 ,H290221 ,H290271 ,H290321 ,H290368 ,H290415 ,H290538 ,H291023 ,H291070 ,H291118 ,H290168 ,H290222 ,H290272 ,H290322 ,H290369 ,H290416 ,H290539 ,H291024 ,H291071 ,H291119 ,H290171 ,H290223 ,H290273 ,H290323 ,H290370 ,H290417 ,H290540 ,H291025 ,H291072 ,H291120 ,H290173 ,H290224 ,H290274 ,H290324 ,H290371 ,H290422 ,H290541 ,H291026 ,H291073 ,H291121 ,H290175 ,H290225 ,H290275 ,H290325 ,H290372 ,H290423 ,H290542 ,H291027 ,H291074 ,H291122 ,H290176 ,H290226 ,H290276 ,H290326 ,H290373 ,H290424 ,H290543 ,H291028 ,H291075 ,H291123     ,H291124 ,H291171 ,H291218 ,H291265 ,H293334 ,H293382 ,H293430 ,H293477 ,H293524 ,H293574 ,H291125 ,H291172 ,H291219 ,H291266 ,H293335 ,H293383 ,H293431 ,H293478 ,H293525 ,H293575 ,H291126 ,H291173 ,H291220 ,H291267 ,H293336 ,H293384 ,H293432 ,H293479 ,H293527 ,H293576 ,H291127 ,H291174 ,H291221 ,H291268 ,H293337 ,H293385 ,H293433 ,H293480 ,H293529 ,H293577 ,H291128 ,H291175 ,H291222 ,H291269 ,H293339 ,H293386 ,H293434 ,H293481 ,H293530 ,H293578 ,H291129 ,H291176 ,H291223 ,H291270 ,H293340 ,H293387 ,H293435 ,H293482 ,H293531 ,H293579 ,H291130 ,H291177 ,H291224 ,H291271 ,H293341 ,H293388 ,H293436 ,H293483 ,H293532 ,H293581 ,H291131 ,H291178 ,H291225 ,H291272 ,H293342 ,H293389 ,H293437 ,H293484 ,H293533 ,H293583 ,H291132 ,H291179 ,H291226 ,H291273 ,H293343 ,H293390 ,H293438 ,H293485 ,H293534 ,H293584 ,H291133 ,H291180 ,H291227 ,H292366 ,H293344 ,H293391 ,H293439 ,H293486 ,H293535 ,H293585 ,H291134 ,H291181 ,H291228 ,H292832 ,H293345 ,H293392 ,H293440 ,H293487 ,H293536 ,H293586 ,H291135 ,H291182 ,H291229 ,H293009 ,H293346 ,H293393 ,H293441 ,H293488 ,H293537 ,H293587 ,H291136 ,H291183 ,H291230 ,H293207 ,H293347 ,H293394 ,H293442 ,H293489 ,H293538 ,H293588 ,H291137 ,H291184 ,H291231 ,H293300 ,H293348 ,H293395 ,H293443 ,H293490 ,H293539 ,H293589 ,H291138 ,H291185 ,H291232 ,H293301 ,H293349 ,H293396 ,H293444 ,H293491 ,H293540 ,H293590 ,H291139 ,H291186 ,H291233 ,H293302 ,H293350 ,H293397 ,H293445 ,H293492 ,H293541 ,H293591 ,H291140 ,H291187 ,H291234 ,H293303 ,H293351 ,H293398 ,H293446 ,H293493 ,H293542 ,H293592 ,H291141 ,H291188 ,H291235 ,H293304 ,H293352 ,H293399 ,H293447 ,H293494 ,H293543 ,H293593 ,H291142 ,H291189 ,H291236 ,H293305 ,H293353 ,H293401 ,H293448 ,H293495 ,H293544 ,H293594 ,H291143 ,H291190 ,H291237 ,H293306 ,H293354 ,H293402 ,H293449 ,H293496 ,H293545 ,H293595 ,H291144 ,H291191 ,H291238 ,H293307 ,H293355 ,H293403 ,H293450 ,H293497 ,H293546 ,H293596 ,H291145 ,H291192 ,H291239 ,H293308 ,H293356 ,H293404 ,H293451 ,H293498 ,H293548 ,H293597 ,H291146 ,H291193 ,H291240 ,H293309 ,H293357 ,H293405 ,H293452 ,H293499 ,H293549 ,H293598 ,H291147 ,H291194 ,H291241 ,H293310 ,H293358 ,H293406 ,H293453 ,H293500 ,H293550 ,H293599 ,H291148 ,H291195 ,H291242 ,H293311 ,H293359 ,H293407 ,H293454 ,H293501 ,H293551 ,H293600 ,H291149 ,H291196 ,H291243 ,H293312 ,H293360 ,H293408 ,H293455 ,H293502 ,H293552 ,H293601 ,H291150 ,H291197 ,H291244 ,H293313 ,H293361 ,H293409 ,H293456 ,H293503 ,H293553 ,H293602 ,H291151 ,H291198 ,H291245 ,H293314 ,H293362 ,H293410 ,H293457 ,H293504 ,H293554 ,H293603 ,H291152 ,H291199 ,H291246 ,H293315 ,H293363 ,H293411 ,H293458 ,H293505 ,H293555 ,H293604 ,H291153 ,H291200 ,H291247 ,H293316 ,H293364 ,H293412 ,H293459 ,H293506 ,H293556 ,H293605 ,H291154 ,H291201 ,H291248 ,H293317 ,H293365 ,H293413 ,H293460 ,H293507 ,H293557 ,H293606 ,H291155 ,H291202 ,H291249 ,H293318 ,H293366 ,H293414 ,H293461 ,H293508 ,H293558 ,H293607 ,H291156 ,H291203 ,H291250 ,H293319 ,H293367 ,H293415 ,H293462 ,H293509 ,H293559 ,H293608 ,H291157 ,H291204 ,H291251 ,H293320 ,H293368 ,H293416 ,H293463 ,H293510 ,H293560 ,H293609 ,H291158 ,H291205 ,H291252 ,H293321 ,H293369 ,H293417 ,H293464 ,H293511 ,H293561 ,H293610 ,H291159 ,H291206 ,H291253 ,H293322 ,H293370 ,H293418 ,H293465 ,H293512 ,H293562 ,H293611 ,H291160 ,H291207 ,H291254 ,H293323 ,H293371 ,H293419 ,H293466 ,H293513 ,H293563 ,H293612 ,H291161 ,H291208 ,H291255 ,H293324 ,H293372 ,H293420 ,H293467 ,H293514 ,H293564 ,H293613 ,H291162 ,H291209 ,H291256 ,H293325 ,H293373 ,H293421 ,H293468 ,H293515 ,H293565 ,H293614 ,H291163 ,H291210 ,H291257 ,H293326 ,H293374 ,H293422 ,H293469 ,H293516 ,H293566 ,H293615 ,H291164 ,H291211 ,H291258 ,H293327 ,H293375 ,H293423 ,H293470 ,H293517 ,H293567 ,H293616 ,H291165 ,H291212 ,H291259 ,H293328 ,H293376 ,H293424 ,H293471 ,H293518 ,H293568 ,H293617 ,H291166 ,H291213 ,H291260 ,H293329 ,H293377 ,H293425 ,H293472 ,H293519 ,H293569 ,H293618 ,H291167 ,H291214 ,H291261 ,H293330 ,H293378 ,H293426 ,H293473 ,H293520 ,H293570 ,H293619 ,H291168 ,H291215 ,H291262 ,H293331 ,H293379 ,H293427 ,H293474 ,H293521 ,H293571 ,H293620 ,H291169 ,H291216 ,H291263 ,H293332 ,H293380 ,H293428 ,H293475 ,H293522 ,H293572 ,H293621 ,H291170 ,H291217 ,H291264 ,H293333 ,H293381 ,H293429 ,H293476 ,H293523 ,H293573 ,H293622     ,H293623 ,H293670 ,H293719 ,H293771 ,H293820 ,H293868 ,H293915 ,H293968 ,H294018 ,H294068 ,H293624 ,H293671 ,H293720 ,H293772 ,H293821 ,H293869 ,H293916 ,H293969 ,H294020 ,H294069 ,H293625 ,H293672 ,H293721 ,H293773 ,H293822 ,H293870 ,H293917 ,H293970 ,H294021 ,H294070 ,H293626 ,H293673 ,H293723 ,H293774 ,H293823 ,H293871 ,H293918 ,H293971 ,H294022 ,H294071 ,H293627 ,H293674 ,H293724 ,H293775 ,H293824 ,H293872 ,H293919 ,H293972 ,H294023 ,H294072 ,H293628 ,H293675 ,H293725 ,H293776 ,H293825 ,H293873 ,H293920 ,H293974 ,H294024 ,H294073 ,H293629 ,H293676 ,H293726 ,H293777 ,H293826 ,H293874 ,H293921 ,H293975 ,H294025 ,H294074 ,H293630 ,H293677 ,H293727 ,H293778 ,H293827 ,H293875 ,H293922 ,H293976 ,H294026 ,H294075 ,H293631 ,H293678 ,H293728 ,H293779 ,H293828 ,H293876 ,H293923 ,H293977 ,H294027 ,H294076 ,H293632 ,H293679 ,H293729 ,H293780 ,H293829 ,H293877 ,H293924 ,H293978 ,H294028 ,H294077 ,H293633 ,H293681 ,H293730 ,H293781 ,H293830 ,H293878 ,H293925 ,H293979 ,H294029 ,H294078 ,H293634 ,H293682 ,H293732 ,H293782 ,H293831 ,H293879 ,H293926 ,H293980 ,H294030 ,H294079 ,H293635 ,H293683 ,H293733 ,H293783 ,H293832 ,H293880 ,H293928 ,H293981 ,H294031 ,H294080 ,H293636 ,H293684 ,H293734 ,H293784 ,H293834 ,H293881 ,H293929 ,H293982 ,H294032 ,H294081 ,H293637 ,H293685 ,H293735 ,H293785 ,H293835 ,H293882 ,H293930 ,H293983 ,H294033 ,H294082 ,H293638 ,H293686 ,H293736 ,H293786 ,H293836 ,H293883 ,H293931 ,H293984 ,H294034 ,H294083 ,H293639 ,H293687 ,H293737 ,H293787 ,H293837 ,H293884 ,H293932 ,H293985 ,H294035 ,H294084 ,H293640 ,H293688 ,H293738 ,H293788 ,H293838 ,H293885 ,H293933 ,H293986 ,H294036 ,H294085 ,H293641 ,H293689 ,H293739 ,H293789 ,H293839 ,H293886 ,H293934 ,H293987 ,H294037 ,H294086 ,H293642 ,H293690 ,H293740 ,H293790 ,H293840 ,H293887 ,H293935 ,H293988 ,H294038 ,H294088 ,H293643 ,H293691 ,H293741 ,H293791 ,H293841 ,H293888 ,H293936 ,H293989 ,H294039 ,H294089 ,H293644 ,H293692 ,H293742 ,H293792 ,H293842 ,H293889 ,H293938 ,H293990 ,H294040 ,H294090 ,H293645 ,H293693 ,H293743 ,H293793 ,H293843 ,H293890 ,H293941 ,H293991 ,H294041 ,H294091 ,H293646 ,H293694 ,H293744 ,H293794 ,H293844 ,H293891 ,H293942 ,H293992 ,H294042 ,H294092 ,H293647 ,H293695 ,H293745 ,H293795 ,H293845 ,H293892 ,H293943 ,H293993 ,H294043 ,H294093 ,H293648 ,H293696 ,H293746 ,H293796 ,H293846 ,H293893 ,H293944 ,H293994 ,H294044 ,H294095 ,H293649 ,H293697 ,H293747 ,H293797 ,H293847 ,H293894 ,H293946 ,H293995 ,H294045 ,H294097 ,H293650 ,H293698 ,H293748 ,H293798 ,H293848 ,H293895 ,H293947 ,H293996 ,H294046 ,H294098 ,H293651 ,H293699 ,H293749 ,H293799 ,H293849 ,H293896 ,H293948 ,H293997 ,H294047 ,H294099 ,H293652 ,H293700 ,H293750 ,H293800 ,H293850 ,H293897 ,H293949 ,H293998 ,H294048 ,H294100 ,H293653 ,H293701 ,H293751 ,H293801 ,H293851 ,H293898 ,H293950 ,H293999 ,H294049 ,H294101 ,H293654 ,H293702 ,H293752 ,H293802 ,H293852 ,H293899 ,H293951 ,H294000 ,H294050 ,H294102 ,H293655 ,H293703 ,H293753 ,H293803 ,H293853 ,H293900 ,H293952 ,H294001 ,H294051 ,H294103 ,H293656 ,H293704 ,H293754 ,H293804 ,H293854 ,H293901 ,H293953 ,H294002 ,H294052 ,H294104 ,H293657 ,H293705 ,H293755 ,H293805 ,H293855 ,H293902 ,H293954 ,H294003 ,H294053 ,H294105 ,H293658 ,H293706 ,H293756 ,H293806 ,H293856 ,H293903 ,H293955 ,H294004 ,H294054 ,H294106 ,H293659 ,H293707 ,H293758 ,H293807 ,H293857 ,H293904 ,H293956 ,H294005 ,H294055 ,H294107 ,H293660 ,H293708 ,H293759 ,H293808 ,H293858 ,H293905 ,H293957 ,H294006 ,H294056 ,H294108 ,H293661 ,H293709 ,H293760 ,H293809 ,H293859 ,H293906 ,H293958 ,H294007 ,H294058 ,H294109 ,H293662 ,H293710 ,H293761 ,H293812 ,H293860 ,H293907 ,H293959 ,H294008 ,H294059 ,H294110 ,H293663 ,H293712 ,H293762 ,H293813 ,H293861 ,H293908 ,H293960 ,H294009 ,H294060 ,H294111 ,H293664 ,H293713 ,H293763 ,H293814 ,H293862 ,H293909 ,H293962 ,H294010 ,H294061 ,H294112 ,H293665 ,H293714 ,H293764 ,H293815 ,H293863 ,H293910 ,H293963 ,H294011 ,H294062 ,H294113 ,H293666 ,H293715 ,H293765 ,H293816 ,H293864 ,H293911 ,H293964 ,H294012 ,H294063 ,H294114 ,H293667 ,H293716 ,H293767 ,H293817 ,H293865 ,H293912 ,H293965 ,H294013 ,H294064 ,H294116 ,H293668 ,H293717 ,H293769 ,H293818 ,H293866 ,H293913 ,H293966 ,H294016 ,H294065 ,H294117 ,H293669 ,H293718 ,H293770 ,H293819 ,H293867 ,H293914 ,H293967 ,H294017 ,H294067 ,H294118     ,H294119 ,H294173 ,H294224 ,H294282 ,H294337 ,H294403 ,H294120 ,H294174 ,H294225 ,H294283 ,H294338 ,H294404 ,H294121 ,H294175 ,H294226 ,H294285 ,H294340 ,H294408 ,H294122 ,H294176 ,H294227 ,H294286 ,H294341 ,H294409 ,H294123 ,H294177 ,H294228 ,H294287 ,H294342 ,H294410 ,H294124 ,H294178 ,H294230 ,H294288 ,H294343 ,H294412 ,H294125 ,H294179 ,H294231 ,H294289 ,H294346 ,H294413 ,H294126 ,H294180 ,H294232 ,H294292 ,H294348 ,H294414 ,H294127 ,H294181 ,H294233 ,H294293 ,H294350 ,H294417 ,H294128 ,H294182 ,H294234 ,H294294 ,H294353 ,H294419 ,H294129 ,H294183 ,H294235 ,H294295 ,H294354 ,H294420 ,H294130 ,H294184 ,H294236 ,H294296 ,H294355 ,H294421 ,H294131 ,H294185 ,H294237 ,H294297 ,H294356 ,H294425 ,H294132 ,H294186 ,H294239 ,H294298 ,H294357 ,H294427 ,H294133 ,H294187 ,H294240 ,H294299 ,H294358 ,H294428 ,H294134 ,H294188 ,H294241 ,H294301 ,H294360 ,H294429 ,H294135 ,H294189 ,H294242 ,H294302 ,H294361 ,H294432 ,H294136 ,H294190 ,H294243 ,H294303 ,H294362 ,H294436 ,H294137 ,H294191 ,H294244 ,H294304 ,H294363 ,H294442 ,H294140 ,H294192 ,H294245 ,H294305 ,H294364 ,H294460 ,H294142 ,H294193 ,H294246 ,H294306 ,H294365 ,H294519 ,H294143 ,H294194 ,H294247 ,H294307 ,H294366 ,H294529 ,H294144 ,H294195 ,H294248 ,H294308 ,H294367 ,H294581 ,H294145 ,H294196 ,H294252 ,H294309 ,H294368  ,H294146 ,H294197 ,H294253 ,H294312 ,H294370  ,H294148 ,H294198 ,H294254 ,H294313 ,H294371  ,H294149 ,H294199 ,H294256 ,H294314 ,H294372  ,H294150 ,H294200 ,H294257 ,H294315 ,H294373  ,H294151 ,H294201 ,H294258 ,H294316 ,H294376  ,H294152 ,H294202 ,H294261 ,H294317 ,H294377  ,H294154 ,H294203 ,H294262 ,H294318 ,H294378  ,H294155 ,H294204 ,H294263 ,H294320 ,H294380  ,H294156 ,H294205 ,H294264 ,H294321 ,H294381  ,H294157 ,H294207 ,H294266 ,H294322 ,H294382  ,H294158 ,H294208 ,H294267 ,H294323 ,H294383  ,H294159 ,H294209 ,H294269 ,H294324 ,H294384  ,H294161 ,H294210 ,H294270 ,H294325 ,H294385  ,H294162 ,H294211 ,H294271 ,H294326 ,H294386  ,H294163 ,H294214 ,H294272 ,H294327 ,H294389  ,H294164 ,H294216 ,H294273 ,H294328 ,H294392  ,H294165 ,H294217 ,H294275 ,H294330 ,H294393  ,H294166 ,H294218 ,H294276 ,H294331 ,H294394  ,H294167 ,H294219 ,H294277 ,H294332 ,H294395  ,H294168 ,H294220 ,H294278 ,H294333 ,H294396  ,H294169 ,H294221 ,H294279 ,H294334 ,H294397  ,H294170 ,H294222 ,H294280 ,H294335 ,H294398  ,H294172 ,H294223 ,H294281 ,H294336 ,H294399.  Jupdate 7-9-2013: The following code numbers were determined not be affected by the correction and therefore should be removed: Cl Devices Serial Numbers:   C2 Devices Serial Numbers: H270209 H270438 H270211 H270439 H270214 H270443 H270215 H270446 H270216 H270447 H270219 H270448 H270232 H270452 H270235 H270458 H270244 H270461 H270251 H270462 H270254 H270464 H270255 H270473 H270256 H270474 H270260 H270476 H270261 H270477 H270273 H270479 H270280 H270482 H270281 H270483 H270282 H270487 H270290 H270489 H270293 H270490 H270302 H270491 H270303 H270498 H270307 H270500 H270310 H270501 H270314 H270502 H270316 H270503 H270323 H270504 H270332 H270506 H270338 H270508 H270341 H270511 H270344 H270513 H270345 H270515 H270351 H270516 H270352 H270518 H270355 H270520 H270356 H270522 H270360 H270525 H270370 H270526 H270371 H270532 H270378 H270534 H270383 H 270535 H270384 H270540 H270385 H 270544 H270386 H290002 H270392 H290004 H270395 H 290025 H270400 H290026 H270401 H290027 H270416 H290030 H270421 H290031 H270425 H290032 H270426 H290033 H270427  H270428  H270431  H270432  H270437      
Recalling Firm/
Varian Medical Systems Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Dave Hall
Manufacturer Reason
for Recall
A circuit design anomaly whereby a faulty balance potentiometer can lead to an undetected electron beam asymmetry.
FDA Determined
Cause 2
Device Design
Action The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 1, 2009 via Federal Express to consignees/customers. The letter described the product, problem and actions to be taken by the customers and the firm. The customers were instructed to perform a verification of field symmetry on electron beam energies to determine the threshold and report any field symmetry issues to their local Varian service office for attention. The firm, Varian, is developing new functionality to detect the symptoms of this component failure condition under all conditions of electron beam operations and asserting a beam interlock if it is detected. Note: Varian indicated until the solution can be developed, they will conduct an audit of installed Clinacs to identify those the suspect "blue" electron beam balance potentiometers installed, and will execute a program of prophylactic replacement of these potentiometers. If you require further clarification, please contact your local Varian Customer Support District or Regional Manager at phone: USA and Canada-1-888-VARIANS (888-827-4265); Europe- +41 41 749-8844 or email support-emea@varian.com; North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; South East Asia: seasia.apps.helpdes@varian.com; China/Asia: china.apps.helpdesk@varian.com; Japan: Japan.apps.helpdesk@varian.com; Latin America: soporte.al@varian.com; Internet: Oncology Systems - www.myvarian.com; Varian Medical Systems -www.varian.com
Quantity in Commerce 4411
Distribution USA and countries including: Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Belorussia, Bolivia, Brazil, Canada, Chile,, China, Columbia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France,French Polynesia, Germany, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Lebanan, Luxembourg, Maca, Macedonia, Malaysia, Martinique, Mexico, Moldova, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan,, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea,, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Uruguay..
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, INC.