Events

Device Recall Varian Unique Single Energy Linear Accelerator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems, Inc. Oncology Systems 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    60659
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0483-2012
  • 사례 시작날짜
    2011-11-28
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106143
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Accelerator, linear, medical - Product Code IYE
  • 원인
    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.
  • 조치
    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 Unique Single Energy Linear Accelerator
  • 모델명 / 제조번호(시리얼번호)
    H140001 ,H140145 ,H140711 ,H140772 ,H140832 ,H140893 ,H140958 ,H271265 ,H271742 ,H272014 ,H272235 ,H272416 ,H272858  ,H140011 ,H140146 ,H140712 ,H140773 ,H140833 ,H140895 ,H140959 ,H271277 ,H271755 ,H272016 ,H272236 ,H272418 ,H272859  ,H140018 ,H140147 ,H140713 ,H140774 ,H140834 ,H140896 ,H140962 ,H271293 ,H271760 ,H272023 ,H272237 ,H272421 ,H272860  ,H140025 ,H140148 ,H140714 ,H140775 ,H140835 ,H140897 ,H140963 ,H271308 ,H271762 ,H272029 ,H272239 ,H272422 ,H272862  ,H140026 ,H140150 ,H140715 ,H140776 ,H140836 ,H140898 ,H180455 ,H271334 ,H271763 ,H272031 ,H272240 ,H272423 ,H272864  ,H140027 ,H140151 ,H140716 ,H140777 ,H140837 ,H140899 ,H182000 ,H271362 ,H271773 ,H272033 ,H272243 ,H272425 ,H272866  ,H140029 ,H140152 ,H140717 ,H140778 ,H140838 ,H140900 ,H182001 ,H271370 ,H271780 ,H272035 ,H272250 ,H272426 ,H272868  ,H140031 ,H140153 ,H140718 ,H140779 ,H140839 ,H140901 ,H182002 ,H271378 ,H271783 ,H272043 ,H272259 ,H272427 ,H272872  ,H140038 ,H140154 ,H140719 ,H140780 ,H140840 ,H140902 ,H182003 ,H271385 ,H271785 ,H272045 ,H272260 ,H272428 ,H272873  ,H140039 ,H140201 ,H140720 ,H140781 ,H140841 ,H140903 ,H182005 ,H271393 ,H271797 ,H272049 ,H272271 ,H272432 ,H272876  ,H140043 ,H140202 ,H140721 ,H140782 ,H140842 ,H140904 ,H182006 ,H271407 ,H271801 ,H272050 ,H272277 ,H272434 ,H272885  ,H140045 ,H140203 ,H140722 ,H140783 ,H140843 ,H140905 ,H182007 ,H271413 ,H271802 ,H272052 ,H272283 ,H272438 ,H272889  ,H140046 ,H140204 ,H140723 ,H140784 ,H140844 ,H140906 ,H182008 ,H271414 ,H271811 ,H272062 ,H272290 ,H272440 ,H272890  ,H140047 ,H140205 ,H140724 ,H140785 ,H140845 ,H140907 ,H182009 ,H271420 ,H271825 ,H272064 ,H272291 ,H272444 ,H272893  ,H140048 ,H140206 ,H140725 ,H140786 ,H140846 ,H140908 ,H182010 ,H271425 ,H271831 ,H272069 ,H272293 ,H272445 ,H272899  ,H140058 ,H140207 ,H140726 ,H140787 ,H140847 ,H140909 ,H182011 ,H271429 ,H271833 ,H272078 ,H272299 ,H272446 ,H272905  ,H140062 ,H140208 ,H140727 ,H140788 ,H140848 ,H140910 ,H182012 ,H271438 ,H271835 ,H272081 ,H272301 ,H272454 ,H272908  ,H140067 ,H140209 ,H140728 ,H140789 ,H140849 ,H140911 ,H182013 ,H271439 ,H271838 ,H272085 ,H272302 ,H272456 ,H272909  ,H140070 ,H140210 ,H140729 ,H140790 ,H140850 ,H140912 ,H182014 ,H271440 ,H271845 ,H272086 ,H272306 ,H272458 ,H272910  ,H140071 ,H140211 ,H140730 ,H140791 ,H140851 ,H140913 ,H182016 ,H271443 ,H271853 ,H272089 ,H272307 ,H272460 ,H272911  ,H140073 ,H140212 ,H140731 ,H140792 ,H140852 ,H140914 ,H182017 ,H271452 ,H271856 ,H272111 ,H272309 ,H272462 ,H272912  ,H140076 ,H140213 ,H140732 ,H140793 ,H140853 ,H140915 ,H182018 ,H271490 ,H271858 ,H272115 ,H272310 ,H272464 ,H272914  ,H140077 ,H140214 ,H140733 ,H140794 ,H140854 ,H140916 ,H182019 ,H271497 ,H271860 ,H272118 ,H272311 ,H272466 ,H272922  ,H140078 ,H140215 ,H140734 ,H140795 ,H140855 ,H140917 ,H182020 ,H271502 ,H271862 ,H272129 ,H272313 ,H272469 ,H272926  ,H140079 ,H140216 ,H140735 ,H140796 ,H140856 ,H140918 ,H182021 ,H271507 ,H271866 ,H272134 ,H272318 ,H272470 ,H272932  ,H140088 ,H140217 ,H140736 ,H140797 ,H140857 ,H140919 ,H182022 ,H271515 ,H271870 ,H272136 ,H272321 ,H272473 ,H272933  ,H140090 ,H140218 ,H140737 ,H140798 ,H140858 ,H140920 ,H182023 ,H271519 ,H271872 ,H272137 ,H272324 ,H272476 ,H272936  ,H140092 ,H140219 ,H140738 ,H140799 ,H140859 ,H140921 ,H182030 ,H271523 ,H271875 ,H272138 ,H272325 ,H272479 ,H272938  ,H140096 ,H140220 ,H140739 ,H140800 ,H140860 ,H140922 ,H182032 ,H271526 ,H271877 ,H272143 ,H272326 ,H272480 ,H272941  ,H140097 ,H140221 ,H140740 ,H140801 ,H140861 ,H140923 ,H260905 ,H271531 ,H271879 ,H272153 ,H272327 ,H272488 ,H272946  ,H140098 ,H140222 ,H140742 ,H140802 ,H140862 ,H140924 ,H260909 ,H271534 ,H271881 ,H272155 ,H272328 ,H272491 ,H272951  ,H140101 ,H140223 ,H140743 ,H140803 ,H140863 ,H140925 ,H260922 ,H271559 ,H271890 ,H272156 ,H272329 ,H272492 ,H272953  ,H140107 ,H140224 ,H140744 ,H140804 ,H140864 ,H140926 ,H260924 ,H271582 ,H271893 ,H272157 ,H272333 ,H272494 ,H272956  ,H140109 ,H140225 ,H140745 ,H140805 ,H140865 ,H140927 ,H260925 ,H271587 ,H271895 ,H272158 ,H272336 ,H272497 ,H272960  ,H140111 ,H140226 ,H140746 ,H140806 ,H140866 ,H140929 ,H260928 ,H271588 ,H271896 ,H272159 ,H272339 ,H272500 ,H272961  ,H140113 ,H140227 ,H140747 ,H140807 ,H140867 ,H140930 ,H260931 ,H271593 ,H271903 ,H272162 ,H272341 ,H272801 ,H272963  ,H140114 ,H140228 ,H140748 ,H140808 ,H140868 ,H140931 ,H260936 ,H271594 ,H271905 ,H272163 ,H272343 ,H272803 ,H272964     ,H140115 ,H140229 ,H140749 ,H140809 ,H140869 ,H140932 ,H260940 ,H271602 ,H271906 ,H272168 ,H272345 ,H272804 ,H272968  ,H140116 ,H140230 ,H140750 ,H140810 ,H140870 ,H140933 ,H260942 ,H271607 ,H271918 ,H272169 ,H272346 ,H272805 ,H272971  ,H140117 ,H140231 ,H140751 ,H140811 ,H140871 ,H140934 ,H260946 ,H271618 ,H271921 ,H272172 ,H272349 ,H272806 ,H272973  ,H140118 ,H140232 ,H140752 ,H140812 ,H140872 ,H140935 ,H260949 ,H271624 ,H271926 ,H272173 ,H272354 ,H272811 ,H272978  ,H140119 ,H140233 ,H140753 ,H140813 ,H140873 ,H140936 ,H260950 ,H271626 ,H271931 ,H272174 ,H272355 ,H272816 ,H272981  ,H140121 ,H140234 ,H140754 ,H140814 ,H140874 ,H140937 ,H260951 ,H271628 ,H271935 ,H272178 ,H272359 ,H272820 ,H272982  ,H140122 ,H140235 ,H140755 ,H140815 ,H140875 ,H140938 ,H260952 ,H271635 ,H271941 ,H272179 ,H272360 ,H272822 ,H272985  ,H140124 ,H140236 ,H140756 ,H140816 ,H140876 ,H140939 ,H260953 ,H271640 ,H271942 ,H272180 ,H272362 ,H272824 ,H272986  ,H140125 ,H140237 ,H140757 ,H140817 ,H140877 ,H140940 ,H270767 ,H271662 ,H271951 ,H272184 ,H272365 ,H272825 ,H272987  ,H140129 ,H140238 ,H140758 ,H140818 ,H140878 ,H140941 ,H270788 ,H271663 ,H271954 ,H272187 ,H272370 ,H272826 ,H272990  ,H140132 ,H140239 ,H140759 ,H140819 ,H140879 ,H140942 ,H270794 ,H271664 ,H271961 ,H272188 ,H272372 ,H272827 ,H272993  ,H140133 ,H140240 ,H140760 ,H140820 ,H140881 ,H140943 ,H271041 ,H271669 ,H271964 ,H272195 ,H272377 ,H272828 ,H272996  ,H140134 ,H140700 ,H140761 ,H140821 ,H140882 ,H140944 ,H271066 ,H271678 ,H271972 ,H272197 ,H272380 ,H272834 ,H272999  ,H140135 ,H140701 ,H140762 ,H140822 ,H140883 ,H140945 ,H271105 ,H271681 ,H271973 ,H272202 ,H272381 ,H272837 ,H273003  ,H140136 ,H140702 ,H140763 ,H140823 ,H140884 ,H140947 ,H271157 ,H271691 ,H271974 ,H272203 ,H272388 ,H272841 ,H273004  ,H140137 ,H140703 ,H140764 ,H140824 ,H140885 ,H140948 ,H271158 ,H271693 ,H271975 ,H272204 ,H272394 ,H272842 ,H273006  ,H140138 ,H140704 ,H140765 ,H140825 ,H140886 ,H140949 ,H271159 ,H271711 ,H271976 ,H272209 ,H272397 ,H272846 ,H273011  ,H140139 ,H140705 ,H140766 ,H140826 ,H140887 ,H140950 ,H271167 ,H271712 ,H271993 ,H272216 ,H272401 ,H272847 ,H273016  ,H140140 ,H140706 ,H140767 ,H140827 ,H140888 ,H140951 ,H271194 ,H271713 ,H271994 ,H272219 ,H272405 ,H272848 ,H273026  ,H140141 ,H140707 ,H140768 ,H140828 ,H140889 ,H140952 ,H271214 ,H271714 ,H272000 ,H272220 ,H272407 ,H272849 ,H273027  ,H140142 ,H140708 ,H140769 ,H140829 ,H140890 ,H140953 ,H271227 ,H271720 ,H272001 ,H272223 ,H272410 ,H272854 ,H273029  ,H140143 ,H140709 ,H140770 ,H140830 ,H140891 ,H140956 ,H271242 ,H271724 ,H272003 ,H272226 ,H272412 ,H272856 ,H273030  ,H140144 ,H140710 ,H140771 ,H140831 ,H140892 ,H140957 ,H271258 ,H271729 ,H272009 ,H272231 ,H272413 ,H272857 ,H273031  ,H273032 ,H273133 ,H273197 ,H290501 ,H291030 ,H291094 ,H291158 ,H291220 ,H293306 ,H293369 ,H293432 ,H293494 ,H293558  ,H273035 ,H273134 ,H273198 ,H290503 ,H291031 ,H291095 ,H291159 ,H291221 ,H293307 ,H293370 ,H293433 ,H293495 ,H293559  ,H273036 ,H273135 ,H273199 ,H290504 ,H291032 ,H291096 ,H291160 ,H291222 ,H293308 ,H293371 ,H293434 ,H293496 ,H293560  ,H273039 ,H273136 ,H273200 ,H290505 ,H291034 ,H291097 ,H291161 ,H291223 ,H293309 ,H293372 ,H293435 ,H293497 ,H293561  ,H273040 ,H273137 ,H273201 ,H290508 ,H291035 ,H291098 ,H291162 ,H291224 ,H293310 ,H293373 ,H293436 ,H293498 ,H293562  ,H273041 ,H273138 ,H273202 ,H290509 ,H291036 ,H291099 ,H291163 ,H291225 ,H293311 ,H293374 ,H293437 ,H293499 ,H293563  ,H273042 ,H273139 ,H273203 ,H290510 ,H291037 ,H291101 ,H291164 ,H291226 ,H293312 ,H293375 ,H293438 ,H293500 ,H293564  ,H273048 ,H273140 ,H273204 ,H290511 ,H291038 ,H291102 ,H291165 ,H291227 ,H293313 ,H293376 ,H293439 ,H293501 ,H293565  ,H273049 ,H273141 ,H273205 ,H290512 ,H291039 ,H291103 ,H291166 ,H291228 ,H293314 ,H293377 ,H293440 ,H293502 ,H293566  ,H273052 ,H273142 ,H273206 ,H290517 ,H291040 ,H291104 ,H291167 ,H291229 ,H293315 ,H293378 ,H293441 ,H293503 ,H293567  ,H273053 ,H273143 ,H273208 ,H290519 ,H291041 ,H291105 ,H291168 ,H291230 ,H293316 ,H293379 ,H293442 ,H293504 ,H293568  ,H273055 ,H273144 ,H273209 ,H290520 ,H291042 ,H291106 ,H291169 ,H291231 ,H293317 ,H293380 ,H293443 ,H293505 ,H293569  ,H273056 ,H273145 ,H273210 ,H290530 ,H291043 ,H291107 ,H291170 ,H291232 ,H293318 ,H293381 ,H293444 ,H293506 ,H293570  ,H273057 ,H273146 ,H273547 ,H290533 ,H291044 ,H291108 ,H291171 ,H291233 ,H293319 ,H293382 ,H293445 ,H293507 ,H293571  ,H273063 ,H273147 ,H273711 ,H290538 ,H291045 ,H291109 ,H291172 ,H291234 ,H293320 ,H293383 ,H293446 ,H293508 ,H293572  ,H273064 ,H273148 ,H273929 ,H290540 ,H291046 ,H291111 ,H291173 ,H291235 ,H293321 ,H293384 ,H293447 ,H293509 ,H293573  ,H273065 ,H273149 ,H290186 ,H290541 ,H291047 ,H291112 ,H291174 ,H291236 ,H293323 ,H293385 ,H293448 ,H293510 ,H293574  ,H273066 ,H273150 ,H290192 ,H290547 ,H291048 ,H291113 ,H291175 ,H291237 ,H293324 ,H293386 ,H293449 ,H293511 ,H293575  ,H273072 ,H273151 ,H290201 ,H290548 ,H291049 ,H291114 ,H291176 ,H291238 ,H293325 ,H293387 ,H293450 ,H293512 ,H293576  ,H273075 ,H273152 ,H290208 ,H290549 ,H291050 ,H291115 ,H291177 ,H291239 ,H293326 ,H293388 ,H293451 ,H293513 ,H293577  ,H273077 ,H273153 ,H290222 ,H290550 ,H291051 ,H291116 ,H291178 ,H291240 ,H293327 ,H293389 ,H293452 ,H293514 ,H293578  ,H273080 ,H273155 ,H290224 ,H290551 ,H291052 ,H291117 ,H291179 ,H291241 ,H293328 ,H293390 ,H293453 ,H293515 ,H293579  ,H273082 ,H273156 ,H290233 ,H290552 ,H291053 ,H291118 ,H291180 ,H291242 ,H293329 ,H293391 ,H293454 ,H293516 ,H293581  ,H273083 ,H273157 ,H290241 ,H290553 ,H291054 ,H291119 ,H291181 ,H291243 ,H293330 ,H293392 ,H293455 ,H293517 ,H293583  ,H273084 ,H273158 ,H290243 ,H290554 ,H291055 ,H291120 ,H291182 ,H291244 ,H293331 ,H293393 ,H293456 ,H293518 ,H293584  ,H273086 ,H273159 ,H290248 ,H290555 ,H291056 ,H291121 ,H291183 ,H291245 ,H293332 ,H293394 ,H293457 ,H293519 ,H293585  ,H273088 ,H273160 ,H290249 ,H290556 ,H291057 ,H291122 ,H291184 ,H291246 ,H293333 ,H293395 ,H293458 ,H293520 ,H293586  ,H273089 ,H273162 ,H290256 ,H290557 ,H291059 ,H291123 ,H291185 ,H291247 ,H293334 ,H293396 ,H293459 ,H293521 ,H293587  ,H273092 ,H273163 ,H290262 ,H290558 ,H291060 ,H291124 ,H291186 ,H291248 ,H293335 ,H293397 ,H293460 ,H293522 ,H293588  ,H273093 ,H273164 ,H290272 ,H290559 ,H291061 ,H291125 ,H291187 ,H291249 ,H293336 ,H293398 ,H293461 ,H293523 ,H293589  ,H273100 ,H273165 ,H290274 ,H290560 ,H291062 ,H291126 ,H291188 ,H291250 ,H293337 ,H293399 ,H293462 ,H293524 ,H293590  ,H273101 ,H273166 ,H290278 ,H290561 ,H291063 ,H291127 ,H291189 ,H291251 ,H293338 ,H293401 ,H293463 ,H293525 ,H293591  ,H273102 ,H273167 ,H290282 ,H290600 ,H291064 ,H291128 ,H291190 ,H291252 ,H293339 ,H293402 ,H293464 ,H293527 ,H293592  ,H273103 ,H273168 ,H290287 ,H291001 ,H291065 ,H291129 ,H291191 ,H291253 ,H293340 ,H293403 ,H293465 ,H293528 ,H293593  ,H273104 ,H273169 ,H290295 ,H291002 ,H291066 ,H291130 ,H291192 ,H291254 ,H293341 ,H293404 ,H293466 ,H293529 ,H293594  ,H273105 ,H273170 ,H290304 ,H291003 ,H291067 ,H291131 ,H291193 ,H291255 ,H293342 ,H293405 ,H293467 ,H293530 ,H293595  ,H273106 ,H273171 ,H290308 ,H291004 ,H291068 ,H291132 ,H291194 ,H291256 ,H293343 ,H293406 ,H293468 ,H293531 ,H293596  ,H273107 ,H273172 ,H290313 ,H291005 ,H291069 ,H291133 ,H291195 ,H291257 ,H293344 ,H293407 ,H293469 ,H293532 ,H293597  ,H273108 ,H273173 ,H290317 ,H291006 ,H291070 ,H291134 ,H291196 ,H291258 ,H293345 ,H293408 ,H293470 ,H293533 ,H293598  ,H273109 ,H273174 ,H290321 ,H291007 ,H291071 ,H291135 ,H291197 ,H291259 ,H293346 ,H293409 ,H293471 ,H293534 ,H293599  ,H273110 ,H273175 ,H290326 ,H291008 ,H291072 ,H291136 ,H291198 ,H291260 ,H293347 ,H293410 ,H293472 ,H293535 ,H293600  ,H273111 ,H273176 ,H290341 ,H291009 ,H291073 ,H291137 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,H294853 ,H294918 ,H294986 ,H295049 ,H295120 ,H295196  ,H294466 ,H294528 ,H294597 ,H294660 ,H294726 ,H294788 ,H294854 ,H294919 ,H294987 ,H295050 ,H295121 ,H295199  ,H294467 ,H294529 ,H294598 ,H294661 ,H294727 ,H294789 ,H294855 ,H294920 ,H294988 ,H295051 ,H295122 ,H295201  ,H294468 ,H294530 ,H294599 ,H294662 ,H294728 ,H294790 ,H294856 ,H294921 ,H294989 ,H295053 ,H295123 ,H295202  ,H294469 ,H294531 ,H294600 ,H294663 ,H294729 ,H294791 ,H294857 ,H294922 ,H294990 ,H295054 ,H295124 ,H295203  ,H294470 ,H294532 ,H294601 ,H294664 ,H294730 ,H294792 ,H294858 ,H294923 ,H294991 ,H295056 ,H295125 ,H295206  ,H294471 ,H294533 ,H294602 ,H294665 ,H294731 ,H294793 ,H294859 ,H294924 ,H294992 ,H295057 ,H295126 ,H295207  ,H294472 ,H294534 ,H294603 ,H294666 ,H294732 ,H294794 ,H294860 ,H294925 ,H294993 ,H295058 ,H295127 ,H295208  ,H294473 ,H294535 ,H294604 ,H294667 ,H294733 ,H294795 ,H294861 ,H294926 ,H294995 ,H295059 ,H295128 ,H295209  ,H294474 ,H294536 ,H294605 ,H294668 ,H294734 ,H294796 ,H294862 ,H294927 ,H294996 ,H295060 ,H295129 ,H295210  ,H294475 ,H294537 ,H294606 ,H294669 ,H294735 ,H294797 ,H294863 ,H294928 ,H294997 ,H295061 ,H295130 ,H295211  ,H294476 ,H294538 ,H294607 ,H294670 ,H294736 ,H294798 ,H294864 ,H294929 ,H294998 ,H295062 ,H295131 ,H295212  ,H294477 ,H294539 ,H294608 ,H294671 ,H294737 ,H294799 ,H294865 ,H294930 ,H294999 ,H295063 ,H295132 ,H295213  ,H294478 ,H294540 ,H294610 ,H294672 ,H294738 ,H294800 ,H294866 ,H294931 ,H295000 ,H295064 ,H295133 ,H295214  ,H294479 ,H294541 ,H294611 ,H294673 ,H294739 ,H294801 ,H294867 ,H294932 ,H295001 ,H295065 ,H295134 ,H295216  ,H294480 ,H294542 ,H294612 ,H294674 ,H294740 ,H294802 ,H294868 ,H294933 ,H295002 ,H295066 ,H295135 ,H295217  ,H294481 ,H294543 ,H294613 ,H294675 ,H294741 ,H294803 ,H294869 ,H294934 ,H295003 ,H295067 ,H295136 ,H295221  ,H294482 ,H294544 ,H294614 ,H294676 ,H294742 ,H294804 ,H294870 ,H294935 ,H295004 ,H295068 ,H295138 ,H295223  ,H294483 ,H294545 ,H294615 ,H294677 ,H294743 ,H294806 ,H294871 ,H294936 ,H295005 ,H295069 ,H295139 ,H295224  ,H294484 ,H294546 ,H294616 ,H294678 ,H294744 ,H294807 ,H294872 ,H294937 ,H295006 ,H295070 ,H295140 ,H295225  ,H294485 ,H294547 ,H294617 ,H294679 ,H294745 ,H294808 ,H294874 ,H294938 ,H295007 ,H295071 ,H295141 ,H295226  ,H294486 ,H294548 ,H294618 ,H294680 ,H294746 ,H294809 ,H294875 ,H294940 ,H295008 ,H295072 ,H295142 ,H295227  ,H294487 ,H294549 ,H294619 ,H294681 ,H294747 ,H294810 ,H294876 ,H294941 ,H295009 ,H295073 ,H295143 ,H295228  ,H294488 ,H294550 ,H294620 ,H294682 ,H294748 ,H294811 ,H294877 ,H294942 ,H295010 ,H295074 ,H295144 ,H295229  ,H294489 ,H294551 ,H294621 ,H294683 ,H294749 ,H294812 ,H294878 ,H294943 ,H295011 ,H295075 ,H295145 ,H295231  ,H294490 ,H294552 ,H294622 ,H294684 ,H294750 ,H294813 ,H294879 ,H294945 ,H295012 ,H295076 ,H295146 ,H295235  ,H294491 ,H294553 ,H294623 ,H294685 ,H294751 ,H294814 ,H294880 ,H294946 ,H295013 ,H295077 ,H295147 ,H295236  ,H294492 ,H294554 ,H294624 ,H294686 ,H294752 ,H294815 ,H294881 ,H294947 ,H295014 ,H295078 ,H295148 ,H295238  ,H294493 ,H294555 ,H294625 ,H294687 ,H294753 ,H294816 ,H294882 ,H294948 ,H295015 ,H295080 ,H295149 ,H295239  ,H294494 ,H294556 ,H294626 ,H294688 ,H294754 ,H294817 ,H294883 ,H294949 ,H295016 ,H295081 ,H295150 ,H295240  ,H294495 ,H294557 ,H294627 ,H294689 ,H294755 ,H294818 ,H294884 ,H294950 ,H295017 ,H295082 ,H295151 ,H295241  ,H294496 ,H294564 ,H294628 ,H294690 ,H294756 ,H294820 ,H294885 ,H294951 ,H295018 ,H295083 ,H295152 ,H295242  ,H294497 ,H294565 ,H294629 ,H294691 ,H294757 ,H294821 ,H294886 ,H294952 ,H295019 ,H295084 ,H295154 ,H295244  ,H294498 ,H294567 ,H294630 ,H294692 ,H294758 ,H294822 ,H294887 ,H294953 ,H295020 ,H295085 ,H295155 ,H295245  ,H294499 ,H294568 ,H294631 ,H294693 ,H294759 ,H294823 ,H294888 ,H294954 ,H295021 ,H295086 ,H295156 ,H295246  ,H294500 ,H294569 ,H294632 ,H294694 ,H294760 ,H294824 ,H294889 ,H294955 ,H295022 ,H295087 ,H295157 ,H295247  ,H294501 ,H294570 ,H294633 ,H294695 ,H294761 ,H294825 ,H294890 ,H294956 ,H295023 ,H295089 ,H295158 ,H295248  ,H294502 ,H294571 ,H294634 ,H294696 ,H294762 ,H294826 ,H294891 ,H294957 ,H295024 ,H295090 ,H295159 ,H295249      ,H294503 ,H294572 ,H294635 ,H294697 ,H294763 ,H294827 ,H294892 ,H294958 ,H295025 ,H295091 ,H295160 ,H295250  ,H294504 ,H294573 ,H294636 ,H294698 ,H294764 ,H294828 ,H294893 ,H294959 ,H295026 ,H295093 ,H295161 ,H295252  ,H294505 ,H294574 ,H294637 ,H294699 ,H294765 ,H294829 ,H294894 ,H294960 ,H295027 ,H295094 ,H295162 ,H295254  ,H294506 ,H294575 ,H294638 ,H294700 ,H294766 ,H294830 ,H294895 ,H294961 ,H295028 ,H295095 ,H295163 ,H295255  ,H294507 ,H294576 ,H294639 ,H294701 ,H294767 ,H294831 ,H294896 ,H294962 ,H295029 ,H295096 ,H295169 ,H295265
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Varian Unique Single Energy Linear Accelerator, C-Series Clinac or Trilogy, versions 7.x and 8.x, Reference/FSCA Identifier: CP-0661; Model Numbers: H14, H18, H27, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || Varian Unique Single Energy Linear Accelerator: The UNIQUE is a Single Energy Linear Accelerator intended to be used for conventional radiotherapy and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. The UNIQUE 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
  • 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