Events

Recall of Device Recall Varian brand High Energy Linear Accelerator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems, Inc. Oncology Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60659
  • Event Risk Class
    Class 2
  • Event Number
    Z-0692-2012
  • Event Initiated Date
    2011-11-28
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106351
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • Reason
    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.
  • 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

Device

Device Recall Varian brand High Energy Linear Accelerator
  • Model / Serial
    ,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 ,H181042 ,H181101 ,H140023 ,H140126 ,H180193 ,H180314 ,H180486 ,H180577 ,H180640 ,H180703 ,H180764 ,H180826 ,H180885 ,H181043 ,H181102 ,H140024 ,H140127 ,H180197 ,H180318 ,H180487 ,H180578 ,H180641 ,H180704 ,H180765 ,H180827 ,H180886 ,H181044 ,H181103 ,H140028 ,H140128 ,H180199 ,H180319 ,H180489 ,H180581 ,H180642 ,H180705 ,H180766 ,H180828 ,H180887 ,H181045 ,H181104 ,H140030 ,H140130 ,H180201 ,H180322 ,H180491 ,H180582 ,H180643 ,H180706 ,H180767 ,H180829 ,H180888 ,H181046 ,H181105 ,H140032 ,H140131 ,H180203 ,H180323 ,H180492 ,H180583 ,H180644 ,H180707 ,H180768 ,H180830 ,H180890 ,H181047 ,H181106 ,H140033 ,H180003 ,H180204 ,H180328 ,H180493 ,H180584 ,H180645 ,H180708 ,H180769 ,H180831 ,H180891 ,H181048 ,H181107 ,H140034 ,H180004 ,H180208 ,H180329 ,H180494 ,H180585 ,H180646 ,H180709 ,H180770 ,H180832 ,H180892 ,H181049 ,H181108 ,H140035 ,H180007 ,H180209 ,H180404 ,H180498 ,H180587 ,H180647 ,H180710 ,H180771 ,H180833 ,H180894 ,H181050 ,H181109 ,H140036 ,H180008 ,H180210 ,H180405 ,H180499 ,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 ,H181118 ,H140052 ,H180049 ,H180226 ,H180424 ,H180518 ,H180597 ,H180658 ,H180721 ,H180781 ,H180843 ,H181002 ,H181061 ,H181119 ,H140053 ,H180050 ,H180228 ,H180425 ,H180519 ,H180598 ,H180659 ,H180722 ,H180782 ,H180844 ,H181003 ,H181062 ,H181120 ,H140054 ,H180052 ,H180229 ,H180426 ,H180520 ,H180599 ,H180660 ,H180723 ,H180783 ,H180845 ,H181004 ,H181063 ,H181121 ,H140055 ,H180056 ,H180233 ,H180427 ,H180521 ,H180600 ,H180661 ,H180724 ,H180784 ,H180847 ,H181005 ,H181064 ,H181123 ,H140056 ,H180058 ,H180235 ,H180433 ,H180522 ,H180601 ,H180662 ,H180725 ,H180785 ,H180848 ,H181006 ,H181065 ,H181124 ,H140057 ,H180059 ,H180236 ,H180434 ,H180527 ,H180602 ,H180663 ,H180726 ,H180786 ,H180849 ,H181007 ,H181066 ,H181125 ,H140059 ,H180065 ,H180237 ,H180437 ,H180528 ,H180603 ,H180664 ,H180727 ,H180788 ,H180850 ,H181008 ,H181067 ,H181126 ,H140060 ,H180066 ,H180238 ,H180440 ,H180529 ,H180604 ,H180665 ,H180729 ,H180789 ,H180851 ,H181009 ,H181068 ,H181127 ,H140061 ,H180073 ,H180240 ,H180441 ,H180532 ,H180605 ,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 ,H181225 ,H270290 ,H270470 ,H270652 ,H270805 ,H271013 ,H271114 ,H271241 ,H271336 ,H271423 ,H271511 ,H271590 ,H181157 ,H181228 ,H270297 ,H270473 ,H270653 ,H270806 ,H271015 ,H271115 ,H271245 ,H271337 ,H271424 ,H271512 ,H271591 ,H181158 ,H181230 ,H270302 ,H270474 ,H270654 ,H270812 ,H271016 ,H271116 ,H271247 ,H271338 ,H271426 ,H271513 ,H271592 ,H181159 ,H189999 ,H270303 ,H270476 ,H270656 ,H270813 ,H271017 ,H271120 ,H271248 ,H271339 ,H271428 ,H271514 ,H271595 ,H181160 ,H260916 ,H270307 ,H270477 ,H270660 ,H270817 ,H271019 ,H271121 ,H271250 ,H271340 ,H271430 ,H271516 ,H271596 ,H181161 ,H260917 ,H270310 ,H270479 ,H270661 ,H270820 ,H271020 ,H271127 ,H271251 ,H271342 ,H271431 ,H271517 ,H271597 ,H181162 ,H260923 ,H270314 ,H270482 ,H270662 ,H270821 ,H271021 ,H271132 ,H271256 ,H271344 ,H271434 ,H271518 ,H271598 ,H181163 ,H260926 ,H270323 ,H270483 ,H270664 ,H270822 ,H271023 ,H271135 ,H271257 ,H271345 ,H271435 ,H271520 ,H271599 ,H181164 ,H260932 ,H270324 ,H270486 ,H270665 ,H270823 ,H271024 ,H271137 ,H271259 ,H271347 ,H271436 ,H271521 ,H271600 ,H181165 ,H260938 ,H270332 ,H270487 ,H270667 ,H270825 ,H271025 ,H271141 ,H271260 ,H271349 ,H271437 ,H271522 ,H271601 ,H181166 ,H260939 ,H270335 ,H270489 ,H270669 ,H270826 ,H271026 ,H271142 ,H271263 ,H271350 ,H271441 ,H271525 ,H271603 ,H181167 ,H260944 ,H270338 ,H270490 ,H270670 ,H270827 ,H271029 ,H271143 ,H271264 ,H271351 ,H271442 ,H271527 ,H271604 ,H181168 ,H260947 ,H270341 ,H270491 ,H270675 ,H270828 ,H271031 ,H271144 ,H271266 ,H271355 ,H271444 ,H271528 ,H271605 ,H181170 ,H270010 ,H270344 ,H270495 ,H270681 ,H270829 ,H271032 ,H271145 ,H271267 ,H271356 ,H271445 ,H271529 ,H271606 ,H181171 ,H270021 ,H270345 ,H270498 ,H270682 ,H270833 ,H271034 ,H271149 ,H271269 ,H271357 ,H271447 ,H271530 ,H271608 ,H181172 ,H270026 ,H270351 ,H270499 ,H270684 ,H270836 ,H271035 ,H271151 ,H271270 ,H271358 ,H271448 ,H271532 ,H271609 ,H181173 ,H270027 ,H270352 ,H270500 ,H270686 ,H270837 ,H271037 ,H271152 ,H271272 ,H271359 ,H271449 ,H271533 ,H271610 ,H181174 ,H270029 ,H270353 ,H270501 ,H270690 ,H270838 ,H271038 ,H271154 ,H271273 ,H271360 ,H271450 ,H271535 ,H271611 ,H181175 ,H270030 ,H270356 ,H270502 ,H270692 ,H270840 ,H271039 ,H271155 ,H271274 ,H271361 ,H271451 ,H271536 ,H271612 ,H181176 ,H270038 ,H270360 ,H270503 ,H270693 ,H270842 ,H271042 ,H271161 ,H271276 ,H271363 ,H271453 ,H271537 ,H271613 ,H181177 ,H270045 ,H270364 ,H270504 ,H270698 ,H270844 ,H271043 ,H271166 ,H271280 ,H271364 ,H271454 ,H271538 ,H271614 ,H181178 ,H270047 ,H270370 ,H270505 ,H270699 ,H270846 ,H271044 ,H271172 ,H271281 ,H271365 ,H271456 ,H271539 ,H271615 ,H181179 ,H270073 ,H270371 ,H270511 ,H270700 ,H270852 ,H271051 ,H271178 ,H271282 ,H271366 ,H271457 ,H271540 ,H271616 ,H181180 ,H270079 ,H270373 ,H270512 ,H270705 ,H270854 ,H271052 ,H271182 ,H271283 ,H271367 ,H271458 ,H271541 ,H271617 ,H181181 ,H270088 ,H270378 ,H270513 ,H270708 ,H270857 ,H271055 ,H271183 ,H271284 ,H271368 ,H271459 ,H271542 ,H271619 ,H181182 ,H270096 ,H270383 ,H270516 ,H270710 ,H270858 ,H271056 ,H271184 ,H271285 ,H271369 ,H271461 ,H271543 ,H271620 ,H181183 ,H270101 ,H270384 ,H270518 ,H270714 ,H270859 ,H271059 ,H271185 ,H271287 ,H271371 ,H271462 ,H271544 ,H271621 ,H181184 ,H270106 ,H270385 ,H270520 ,H270716 ,H270861 ,H271061 ,H271189 ,H271289 ,H271372 ,H271464 ,H271545 ,H271622 ,H181185 ,H270110 ,H270386 ,H270522 ,H270718 ,H270863 ,H271062 ,H271190 ,H271290 ,H271374 ,H271465 ,H271546 ,H271627 ,H181187 ,H270111 ,H270391 ,H270525 ,H270719 ,H270864 ,H271063 ,H271191 ,H271291 ,H271375 ,H271466 ,H271547 ,H271629 ,H181188 ,H270118 ,H270392 ,H270526 ,H270725 ,H270865 ,H271067 ,H271192 ,H271292 ,H271376 ,H271467 ,H271548 ,H271630 ,H181189 ,H270126 ,H270395 ,H270529 ,H270726 ,H270866 ,H271068 ,H271193 ,H271294 ,H271377 ,H271468 ,H271550 ,H271631 ,H181190 ,H270134 ,H270398 ,H270532 ,H270727 ,H270867 ,H271071 ,H271195 ,H271295 ,H271379 ,H271470 ,H271551 ,H271632 ,H181191 ,H270138 ,H270399 ,H270535 ,H270728 ,H270868 ,H271072 ,H271197 ,H271296 ,H271380 ,H271472 ,H271552 ,H271633 ,H181192 ,H270201 ,H270401 ,H270539 ,H270732 ,H270869 ,H271073 ,H271198 ,H271297 ,H271381 ,H271473 ,H271553 ,H271634 ,H181193 ,H270209 ,H270410 ,H270540 ,H270733 ,H270871 ,H271075 ,H271199 ,H271298 ,H271382 ,H271474 ,H271554 ,H271636 ,H181194 ,H270211 ,H270416 ,H270542 ,H270735 ,H270872 ,H271076 ,H271200 ,H271299 ,H271383 ,H271475 ,H271555 ,H271637 ,H181195 ,H270215 ,H270418 ,H270544 ,H270737 ,H270873 ,H271080 ,H271201 ,H271300 ,H271384 ,H271476 ,H271557 ,H271638 ,H181196 ,H270216 ,H270419 ,H270550 ,H270739 ,H270875 ,H271082 ,H271204 ,H271302 ,H271386 ,H271477 ,H271558 ,H271639 ,H181197 ,H270219 ,H270421 ,H270601 ,H270746 ,H270877 ,H271083 ,H271205 ,H271303 ,H271387 ,H271478 ,H271561 ,H271641 ,H181198 ,H270227 ,H270425 ,H270602 ,H270749 ,H270878 ,H271085 ,H271207 ,H271304 ,H271388 ,H271479 ,H271562 ,H271642 ,H181199 ,H270228 ,H270426 ,H270606 ,H270751 ,H270879 ,H271086 ,H271208 ,H271305 ,H271389 ,H271481 ,H271563 ,H271643 ,H181200 ,H270229 ,H270427 ,H270607 ,H270752 ,H270880 ,H271088 ,H271209 ,H271306 ,H271390 ,H271483 ,H271564 ,H271645 ,H181201 ,H270230 ,H270428 ,H270613 ,H270755 ,H270882 ,H271091 ,H271210 ,H271307 ,H271392 ,H271484 ,H271565 ,H271646 ,H181202 ,H270232 ,H270430 ,H270615 ,H270757 ,H270883 ,H271092 ,H271211 ,H271309 ,H271395 ,H271485 ,H271566 ,H271647 ,H181203 ,H270235 ,H270431 ,H270622 ,H270761 ,H270884 ,H271093 ,H271212 ,H271312 ,H271398 ,H271487 ,H271567 ,H271648 ,H181204 ,H270244 ,H270435 ,H270623 ,H270762 ,H270885 ,H271094 ,H271216 ,H271314 ,H271399 ,H271488 ,H271568 ,H271649 ,H181205 ,H270245 ,H270437 ,H270624 ,H270763 ,H270886 ,H271095 ,H271217 ,H271315 ,H271401 ,H271492 ,H271570 ,H271650 ,H181206 ,H270251 ,H270438 ,H270625 ,H270766 ,H270888 ,H271097 ,H271218 ,H271316 ,H271402 ,H271493 ,H271571 ,H271651 ,H181207 ,H270252 ,H270439 ,H270627 ,H270777 ,H270889 ,H271098 ,H271222 ,H271317 ,H271403 ,H271494 ,H271572 ,H271652 ,H181208 ,H270255 ,H270443 ,H270631 ,H270781 ,H270891 ,H271099 ,H271223 ,H271318 ,H271404 ,H271495 ,H271573 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,H272164 ,H272261 ,H272358 ,H272455 ,H272878 ,H272969 ,H273078 ,H271670 ,H271749 ,H271824 ,H271912 ,H271991 ,H272080 ,H272165 ,H272262 ,H272361 ,H272457 ,H272879 ,H272970 ,H273079 ,H271671 ,H271750 ,H271826 ,H271913 ,H271992 ,H272082 ,H272166 ,H272263 ,H272363 ,H272459 ,H272880 ,H272972 ,H273081 ,H271672 ,H271751 ,H271827 ,H271914 ,H271996 ,H272083 ,H272167 ,H272264 ,H272364 ,H272461 ,H272881 ,H272974 ,H273085 ,H271673 ,H271752 ,H271828 ,H271915 ,H271997 ,H272084 ,H272170 ,H272265 ,H272366 ,H272463 ,H272882 ,H272975 ,H273087 ,H271674 ,H271753 ,H271829 ,H271916 ,H271998 ,H272087 ,H272171 ,H272266 ,H272367 ,H272465 ,H272883 ,H272976 ,H273090 ,H271675 ,H271754 ,H271830 ,H271917 ,H271999 ,H272088 ,H272175 ,H272268 ,H272368 ,H272467 ,H272884 ,H272977 ,H273091 ,H271676 ,H271756 ,H271832 ,H271919 ,H272002 ,H272090 ,H272176 ,H272269 ,H272369 ,H272468 ,H272886 ,H272979 ,H273094 ,H271677 ,H271757 ,H271834 ,H271920 ,H272004 ,H272091 ,H272177 ,H272270 ,H272371 ,H272471 ,H272887 ,H272980 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,H290348 ,H290522 ,H290265 ,H290349 ,H290523 ,H290266 ,H290350 ,H290524 ,H290268 ,H290351 ,H290525 ,H290269 ,H290353 ,H290526 ,H290271 ,H290354 ,H290527 ,H290275 ,H290355 ,H290528 ,H290279 ,H290356 ,H290529
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    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.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Manufacturer Address
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA