Events

Retiro De Equipo (Recall) de Device Recall Varian brand High Energy Linear Accelerator

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Varian Medical Systems, Inc. Oncology Systems.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    60659
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0692-2012
  • Fecha de inicio del evento
    2011-11-28
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106351
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Accelerator, linear, medical - Product Code IYE
  • Causa
    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.
  • Acción
    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
  • Modelo / 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 ,H271653 ,H181209 ,H270256 ,H270446 ,H270632 ,H270782 ,H270892 ,H271100 ,H271224 ,H271319 ,H271406 ,H271498 ,H271574 ,H271654   ,H271655 ,H271739 ,H271816 ,H271901 ,H271983 ,H272071 ,H272149 ,H272251 ,H272348 ,H272447 ,H272865 ,H272957 ,H273062 ,H271656 ,H271740 ,H271817 ,H271902 ,H271984 ,H272072 ,H272150 ,H272253 ,H272350 ,H272448 ,H272867 ,H272958 ,H273067 ,H271657 ,H271741 ,H271818 ,H271904 ,H271985 ,H272073 ,H272151 ,H272254 ,H272351 ,H272449 ,H272869 ,H272959 ,H273068 ,H271658 ,H271743 ,H271819 ,H271907 ,H271986 ,H272074 ,H272152 ,H272255 ,H272352 ,H272450 ,H272870 ,H272962 ,H273069 ,H271659 ,H271744 ,H271820 ,H271908 ,H271987 ,H272075 ,H272154 ,H272256 ,H272353 ,H272451 ,H272871 ,H272965 ,H273070 ,H271660 ,H271746 ,H271821 ,H271909 ,H271988 ,H272076 ,H272160 ,H272257 ,H272356 ,H272452 ,H272875 ,H272966 ,H273071 ,H271666 ,H271747 ,H271822 ,H271910 ,H271989 ,H272077 ,H272161 ,H272258 ,H272357 ,H272453 ,H272877 ,H272967 ,H273074 ,H271667 ,H271748 ,H271823 ,H271911 ,H271990 ,H272079 ,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 ,H273095 ,H271679 ,H271758 ,H271836 ,H271922 ,H272005 ,H272092 ,H272181 ,H272272 ,H272373 ,H272472 ,H272888 ,H272983 ,H273097 ,H271680 ,H271759 ,H271837 ,H271923 ,H272006 ,H272093 ,H272182 ,H272273 ,H272374 ,H272475 ,H272891 ,H272984 ,H273098 ,H271682 ,H271761 ,H271839 ,H271924 ,H272007 ,H272094 ,H272183 ,H272274 ,H272375 ,H272477 ,H272892 ,H272988 ,H273099 ,H271683 ,H271764 ,H271840 ,H271925 ,H272010 ,H272095 ,H272185 ,H272276 ,H272376 ,H272478 ,H272894 ,H272989 ,H290001 ,H271684 ,H271765 ,H271841 ,H271927 ,H272011 ,H272096 ,H272186 ,H272278 ,H272378 ,H272482 ,H272895 ,H272991 ,H290003 ,H271685 ,H271766 ,H271842 ,H271928 ,H272012 ,H272097 ,H272189 ,H272279 ,H272379 ,H272483 ,H272896 ,H272992 ,H290004 ,H271686 ,H271768 ,H271843 ,H271929 ,H272013 ,H272098 ,H272190 ,H272280 ,H272382 ,H272484 ,H272897 ,H272994 ,H290014 ,H271687 ,H271769 ,H271844 ,H271930 ,H272015 ,H272099 ,H272191 ,H272281 ,H272383 ,H272485 ,H272898 ,H272995 ,H290026 ,H271688 ,H271770 ,H271846 ,H271932 ,H272017 ,H272100 ,H272192 ,H272282 ,H272384 ,H272489 ,H272900 ,H272997 ,H290030 ,H271689 ,H271771 ,H271847 ,H271933 ,H272018 ,H272101 ,H272193 ,H272284 ,H272385 ,H272490 ,H272901 ,H272998 ,H290031 ,H271692 ,H271772 ,H271848 ,H271934 ,H272019 ,H272102 ,H272194 ,H272285 ,H272386 ,H272493 ,H272902 ,H273000 ,H290032 ,H271695 ,H271774 ,H271849 ,H271936 ,H272020 ,H272103 ,H272196 ,H272286 ,H272387 ,H272495 ,H272903 ,H273001 ,H290033 ,H271696 ,H271775 ,H271850 ,H271937 ,H272021 ,H272104 ,H272198 ,H272287 ,H272389 ,H272496 ,H272904 ,H273002 ,H290034 ,H271697 ,H271776 ,H271851 ,H271938 ,H272022 ,H272106 ,H272199 ,H272288 ,H272390 ,H272800 ,H272906 ,H273005 ,H290104 ,H271698 ,H271777 ,H271852 ,H271939 ,H272024 ,H272107 ,H272200 ,H272289 ,H272391 ,H272802 ,H272907 ,H273007 ,H290105 ,H271699 ,H271778 ,H271854 ,H271940 ,H272025 ,H272108 ,H272201 ,H272292 ,H272392 ,H272807 ,H272913 ,H273008 ,H290109 ,H271700 ,H271779 ,H271855 ,H271943 ,H272026 ,H272109 ,H272205 ,H272294 ,H272393 ,H272808 ,H272915 ,H273010 ,H290110 ,H271701 ,H271781 ,H271857 ,H271944 ,H272027 ,H272110 ,H272206 ,H272295 ,H272395 ,H272809 ,H272916 ,H273012 ,H290111 ,H271702 ,H271782 ,H271859 ,H271945 ,H272028 ,H272112 ,H272207 ,H272296 ,H272396 ,H272810 ,H272917 ,H273013 ,H290113 ,H271703 ,H271784 ,H271861 ,H271946 ,H272030 ,H272113 ,H272208 ,H272297 ,H272398 ,H272812 ,H272918 ,H273014 ,H290114 ,H271704 ,H271786 ,H271863 ,H271947 ,H272032 ,H272114 ,H272210 ,H272298 ,H272399 ,H272813 ,H272919 ,H273017 ,H290116 ,H271705 ,H271787 ,H271864 ,H271948 ,H272034 ,H272116 ,H272211 ,H272300 ,H272400 ,H272814 ,H272920 ,H273018 ,H290118 ,H271706 ,H271788 ,H271865 ,H271949 ,H272036 ,H272117 ,H272212 ,H272303 ,H272402 ,H272815 ,H272921 ,H273019 ,H290121 ,H271707 ,H271789 ,H271867 ,H271950 ,H272038 ,H272119 ,H272213 ,H272304 ,H272403 ,H272817 ,H272923 ,H273020 ,H290122 ,H271708 ,H271790 ,H271868 ,H271952 ,H272039 ,H272121 ,H272215 ,H272305 ,H272404 ,H272818 ,H272924 ,H273021 ,H290123 ,H271709 ,H271791 ,H271869 ,H271953 ,H272040 ,H272122 ,H272217 ,H272308 ,H272406 ,H272819 ,H272925 ,H273022 ,H290125 ,H271710 ,H271792 ,H271871 ,H271955 ,H272041 ,H272123 ,H272218 ,H272312 ,H272408 ,H272821 ,H272927 ,H273023 ,H290128 ,H271715 ,H271793 ,H271873 ,H271956 ,H272046 ,H272124 ,H272221 ,H272314 ,H272409 ,H272823 ,H272928 ,H273024 ,H290130 ,H271716 ,H271794 ,H271874 ,H271957 ,H272047 ,H272125 ,H272222 ,H272315 ,H272411 ,H272829 ,H272929 ,H273025 ,H290132 ,H271717 ,H271795 ,H271876 ,H271958 ,H272048 ,H272126 ,H272224 ,H272316 ,H272414 ,H272830 ,H272930 ,H273028 ,H290135 ,H271718 ,H271796 ,H271878 ,H271959 ,H272051 ,H272127 ,H272227 ,H272317 ,H272415 ,H272831 ,H272931 ,H273033 ,H290137 ,H271719 ,H271798 ,H271880 ,H271960 ,H272053 ,H272128 ,H272228 ,H272319 ,H272417 ,H272833 ,H272934 ,H273034 ,H290138 ,H271722 ,H271799 ,H271882 ,H271962 ,H272054 ,H272130 ,H272229 ,H272320 ,H272419 ,H272836 ,H272935 ,H273037 ,H290139 ,H271723 ,H271800 ,H271883 ,H271963 ,H272055 ,H272131 ,H272230 ,H272322 ,H272420 ,H272838 ,H272937 ,H273038 ,H290141 ,H271725 ,H271803 ,H271884 ,H271965 ,H272056 ,H272132 ,H272232 ,H272323 ,H272424 ,H272839 ,H272939 ,H273043 ,H290145 ,H271726 ,H271804 ,H271885 ,H271967 ,H272057 ,H272133 ,H272233 ,H272330 ,H272429 ,H272840 ,H272940 ,H273044 ,H290151 ,H271727 ,H271805 ,H271886 ,H271968 ,H272058 ,H272135 ,H272234 ,H272331 ,H272430 ,H272843 ,H272942 ,H273045 ,H290152 ,H271728 ,H271806 ,H271887 ,H271969 ,H272059 ,H272139 ,H272238 ,H272332 ,H272431 ,H272844 ,H272943 ,H273046 ,H290154 ,H271731 ,H271807 ,H271888 ,H271970 ,H272060 ,H272140 ,H272241 ,H272334 ,H272433 ,H272845 ,H272944 ,H273047 ,H290155 ,H271732 ,H271808 ,H271889 ,H271971 ,H272061 ,H272141 ,H272242 ,H272335 ,H272435 ,H272850 ,H272947 ,H273050 ,H290156 ,H271733 ,H271809 ,H271891 ,H271977 ,H272063 ,H272142 ,H272244 ,H272337 ,H272436 ,H272851 ,H272948 ,H273051 ,H290157 ,H271734 ,H271810 ,H271892 ,H271978 ,H272065 ,H272144 ,H272245 ,H272338 ,H272437 ,H272852 ,H272949 ,H273054 ,H290158 ,H271735 ,H271812 ,H271894 ,H271979 ,H272066 ,H272145 ,H272246 ,H272340 ,H272439 ,H272853 ,H272950 ,H273058 ,H290159 ,H271736 ,H271813 ,H271897 ,H271980 ,H272067 ,H272146 ,H272247 ,H272342 ,H272441 ,H272855 ,H272952 ,H273059 ,H290160 ,H271737 ,H271814 ,H271898 ,H271981 ,H272068 ,H272147 ,H272248 ,H272344 ,H272442 ,H272861 ,H272954 ,H273060 ,H290161 ,H271738 ,H271815 ,H271899 ,H271982 ,H272070 ,H272148 ,H272249 ,H272347 ,H272443 ,H272863 ,H272955 ,H273061 ,H290162   ,H290164 ,H290280 ,H290357 ,H290531 ,H290165 ,H290281 ,H290359 ,H290532 ,H290166 ,H290283 ,H290360 ,H290534 ,H290168 ,H290284 ,H290363 ,H290535 ,H290173 ,H290285 ,H290364 ,H290536 ,H290175 ,H290286 ,H290365 ,H290537 ,H290176 ,H290288 ,H290366 ,H290539 ,H290181 ,H290289 ,H290367 ,H290542 ,H290182 ,H290290 ,H290368 ,H290543 ,H290185 ,H290291 ,H290369 ,H290544 ,H290187 ,H290292 ,H290370 ,H290545 ,H290189 ,H290293 ,H290373 ,H290546 ,H290191 ,H290296 ,H290374 ,H292832 ,H290193 ,H290297 ,H290377 ,H290194 ,H290299 ,H290378 ,H290195 ,H290301 ,H290380 ,H290196 ,H290302 ,H290382 ,H290197 ,H290305 ,H290383 ,H290198 ,H290306 ,H290384 ,H290203 ,H290307 ,H290385 ,H290206 ,H290309 ,H290387 ,H290209 ,H290310 ,H290388 ,H290210 ,H290311 ,H290389 ,H290211 ,H290312 ,H290390 ,H290212 ,H290314 ,H290393 ,H290213 ,H290315 ,H290394 ,H290214 ,H290316 ,H290395 ,H290215 ,H290318 ,H290396 ,H290216 ,H290319 ,H290398 ,H290217 ,H290320 ,H290404 ,H290219 ,H290322 ,H290406 ,H290220 ,H290323 ,H290408 ,H290223 ,H290324 ,H290409 ,H290225 ,H290325 ,H290410 ,H290226 ,H290327 ,H290411 ,H290227 ,H290328 ,H290412 ,H290229 ,H290329 ,H290413 ,H290231 ,H290330 ,H290415 ,H290235 ,H290331 ,H290416 ,H290236 ,H290332 ,H290417 ,H290237 ,H290333 ,H290424 ,H290239 ,H290334 ,H290425 ,H290240 ,H290335 ,H290426 ,H290242 ,H290336 ,H290427 ,H290244 ,H290337 ,H290500 ,H290246 ,H290338 ,H290502 ,H290247 ,H290339 ,H290506 ,H290250 ,H290340 ,H290507 ,H290255 ,H290342 ,H290513 ,H290257 ,H290343 ,H290514 ,H290258 ,H290344 ,H290515 ,H290259 ,H290345 ,H290516 ,H290260 ,H290346 ,H290518 ,H290261 ,H290347 ,H290521 ,H290264 ,H290348 ,H290522 ,H290265 ,H290349 ,H290523 ,H290266 ,H290350 ,H290524 ,H290268 ,H290351 ,H290525 ,H290269 ,H290353 ,H290526 ,H290271 ,H290354 ,H290527 ,H290275 ,H290355 ,H290528 ,H290279 ,H290356 ,H290529
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    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
  • Dirección del fabricante
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Empresa matriz del fabricante (2017)
    Varian Medical Systems Inc
  • Source
    USFDA