Devices

Device Recall Varian

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers/CODES: HIT0535, HIT2953
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the states of New York and Ohio.
  • 제품 설명
    Varian brand Varian ARIA Oncology Information System, Import Export || application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems
  • 1 Event

제조사

Varian Medical Systems, Inc. Oncology Systems
  • 제조사 주소
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • 제조사 모회사 (2017)
    Varian Medical Systems Inc
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 26 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Varian
  • 모델명 / 제조번호(시리얼번호)
    Affected Serial Numbers: 44, 260, 315, 495, 746, 751, 873, 907, 984, 1098, 1131, and 9045
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was released for distribution to 7 hospitals in the US. Distribution was limited to the following States: CA, MA, NC, SC, PA, and LA. 1 (one) Canadian distribution includes Fraser Valley Cancer Center, Dept. of Radiation Oncology, 13750 96th Ave., Surrey, BC, V3V 1Z2, Canada. Foreign distribution includes Austria, Germany and Finland. The recall was appropriately extended to the user level; i.e., the hospitals/physicians who received the recalled product.
  • 제품 설명
    VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x
  • Manufacturer
    Varian Medical Systems Inc
Device Recall Varian Medical Systems VARiS
  • 모델명 / 제조번호(시리얼번호)
    Version Numbers 6.2.27 and 6.2.35, 510k number K001643, serial numbers H8__ (31901, 50044, 50149, 50181, 50187,50260, 50284, 50315, 50357, 50397, 50430, 50804, 50873, 51096, 51152, 51186, 51082, 51463, 51534, 51580, 51658, 51773, 51787, 59032, 59040, 59041, 59045)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    produt was distributed to 28 medical facilities, 12 in the United states, 16 foreign
  • 제품 설명
    medical device and software systems
  • Manufacturer
    Varian Medical Systems Inc
Device Recall Varian High Energy Linear Accelerator
  • 모델명 / 제조번호(시리얼번호)
    Model numbers H14, H27 and H29. Serial numbers: H140012 H140889 H140900 H140910 H140920 H140766 H140890 H140901 H140911 H140921 H140809 H140891 H140902 H140912 H140923 H140815 H140892 H140903 H140913 H140924 H140838 H140893 H140904 H140914 H140925 H140851 H140895 H140905 H140915 H140926 H140876 H140896 H140906 H140916 H140927 H140886 H140897 H140907 H140917 H140929 H140887 H140898 H140908 H140918 H140930 H140888 H140899 H140909 H140919 H140932 H270817 H271430 H271893 H272242 H290255 H271038 H271435 H271932 H272246 H290415 H271105 H271447 H271949 H272323 H291177 H271198 H271462 H271961 H272396  H271201 H271516 H271975 H272400  H271214 H271521 H271991 H272423  H271250 H271618 H272107 H272445  H271280 H271761 H272125 H272480  H271302 H271843 H272140 H290034  H271311 H271889 H272238 H290192
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) and countries of: Australia, Columbia, Denmark, France, Ireland, Italy, Japan, Morocco, Poland, Portugal, Saudi Arabia, South Korea, Spain, and United Kingdom.
  • 제품 설명
    Clinac Linear Accelerator; || Model numbers H14, H27 and H29. || Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems
Device Recall Varian brand High Energy Linear Accelerator
  • 모델명 / 제조번호(시리얼번호)
    ,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 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,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
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    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
Device Recall Varian Treatment
  • 모델명 / 제조번호(시리얼번호)
    Model H48; Serial numbers: H460150 H462049 H462100 H463014 H463044 H463077 H466021 H466036 H466051 H466067 H460907 H462050 H462123 H463015 H463052 H463078 H466022 H466037 H466052 H466068 H461000 H462051 H462124 H463016 H463053 H463080 H466023 H466038 H466053 H466069 H462003 H462055 H462127 H463017 H463054 H463082 H466024 H466039 H466054 H466075 H462004 H462057 H463000 H463018 H463061 H463083 H466025 H466040 H466055 H466082 H462005 H462061 H463001 H463020 H463062 H463093 H466026 H466041 H466056 H466086 H462006 H462072 H463004 H463024 H463064 H463218 H466027 H466043 H466059 H466091 H462011 H462079 H463006 H463038 H463065 H463377 H466028 H466044 H466061 H466092 H462024 H462080 H463008 H463039 H463068 H465519 H466029 H466045 H466062 H468097 H462030 H462082 H463010 H463040 H463070 H466001 H466030 H466046 H466064 H468098 H462045 H462089 H463012 H463042 H463071 H466011 H466031 H466047 H466065   H462048 H462095 H463013 H463043 H463075   H466017 H466032 H466050 H466066.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Nationwide distribution including the states of AZ, CA, FL, GA, IN, MA, MD, MI, MN, MO, NJ, NY, PA, SC, TN, VA and WV; and the countries of Canada, Austria, Belgium, Brazil, Denmark, Finland, France, Germany, India, Ireland, Italy, Lithuania, Poland, Portugal, Romania, South Africa, South Korea, Spain, Sweden, Switzerland and UK.
  • 제품 설명
    Varian Treatment version 6.6.5052. || Varian Medical Systems, || Palo Alto, Ca || Intended to provide accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device form commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems
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