Recall of CSeries: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators

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

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
    66764
  • Event Risk Class
    Class 2
  • Event Number
    Z-0439-2014
  • Event Initiated Date
    2013-10-24
  • Event Date Posted
    2013-12-03
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2016-01-13
  • Event Source
    USFDA
  • Event Source URL
  • 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
    This correction is to notify users that a solution to a previous correction has been developed and varians reps will be contacting locations to schedule installation.
  • Action
    Varian sent an Urgent Medical Device Correction letter, P/N CP-05645 Rev D dated October 24, 2013 to their affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated all affected sites will be contacted by Varian representatives to schedule an upgrade to their devices. Questions may be directed to 888-827-4265 for USA and Canada. Europe +41 41 749 8844

Device

  • Model / Serial
    Model numbers Hl4, HIS, H27, H29: Serial numbers: H140001 H140136 H140700 H140759 Hl40817 H140875 Hl40937 H140995 Hl82047 H271330 H271664 H271935 H272132 H140011 Hl40137 H140701 H140760 Hl40818 H140876 Hl40938 H140996 Hl82048 H271334 H271666 H271938 H272134 H140018 H140138 Hl40702 H140761 Hl40819 Hl40877 H140939 H140997 Hl82049 H271344 H271669 H271942 H272136 Hl40025 H140139 Hl40703 Hl40762 Hl40820 H140878 H140940 Hl40998 Hl82050 H271362 H271678 H271951 H272137 Hl40026 H140140 Hl40704 Hl40763 H140821 H140879 H140941 H140999 Hl820Sl H271370 H271681 H271954 H272138 Hl40027 Hl40141 Hl40705 Hl40764 H140822 Hl40880 H140942 Hl41000 Hl82054 H271378 H271691 H271958 H272143 H140029 H140142 Hl40706 Hl4076S H140823 H140881 H140943 Hl41001 Hl820SS H27138S H271693 H271959 H272144 Hl40036 H140143 Hl40707 Hl40766 H140824 H140882 H140944 H141002 H182056 H271393 H271711 H271961 H27214S H140038 H140144 H140708 H140767 H14082S H140883 H14094S H141003 Hl82057 H271398 H271712 H271964 H272146 H140039 H14014S H140709 H140768 H140826 H140884 H140946 H141004 Hl82058 H271407 H271713 H271966 H272150 H140043 H140146 H140710 H140769 H140827 H14088S H140947 H141005 Hl82060 H271413 H271714 H271972 H272153 Hl4004S H140147 H140711 H140770 Hl40828 H140886 H140948 H141007 H182061 H271414 H271724 H271973 H272155 Hl40046 H140148 H140712 H140771 H140829 H140888 H140949 H141009 H182062 H271420 H271729 H271974 H272156 H140047 H140150 H140713 H140772 H140830 H140889 H1409SO H141010 Hl82063 H271425 H271742 H271975 H272157 H140048 H140151 H140714 H140773 H140831 H140890 H140951 H141011 H182064 H271429 H271755 H271987 H272158 H140058 H140152 H140715 Hl40774 H140832 H140891 H140952 H141015 H182066 H271438 H271760 H271993 H272159 H140062 H140153 Hl40716 H140775 H140833 H140892 H140953 H141017 Hl82067 H271439 H271762 H271994 H272162 H140067 H140154 H140717 H140776 H140834 H140893 H140954 H141022 Hl82068 H271443 H271763 H272001 H272163 Hl40069 Hl40201 H140718 H140777 H140835 H140895 H140955 H182000 Hl82072 H271452 H271773 H272003 H272168 H140070 H140202 Hl40719 H140778 H140836 H140896 H140956 H182001 Hl82073 H271459 H271780 H272009 H272169 H140071 H140203 Hl40720 Hl40779 H140837 Hl40897 H140957 Hl82002 H182077 H271478 H271783 H272014 H272172 H140074 Hl40204 H140721 H140780 H140838 Hl40900 H140958 H182003 H182078 H271490 H271785 H272016 H272173 H140076 H140205 H140722 H140781 Hl40839 Hl40901 H140959 Hl82004 H182079 H271497 H271787 H272018 H272174 H140077 H140206 H140723 H140782 Hl40840 Hl40902 Hl40960 Hl82005 H182080 H271500 H271801 H272022 H272178 H140078 H140207 Hl40724 H140783 Hl40841 H140903 Hl40961 Hl82006 H182082 H271502 H271802 H272023 H272179 H140079 H140208 H140725 H140784 Hl40842 H140904 H140962 Hl82007 Hl82084 H271507 H271808 H272024 H272180 H140086 Hl40209 H140726 H140785 Hl40843 H140905 Hl40963 Hl82008 H182086 H271512 H271809 H272027 H272181 H140088 H140210 H140727 H140786 H140844 H140906 H140964 Hl82009 Hl82200 H271515 H271815 H272029 H272187 H140090 Hl40211 Hl40728 H140787 H140845 H140907 H140965 Hl82010 Hl82201 H271516 H271825 H272032 H272188 Hl40092 H140212 H140729 H140788 H140846 H140908 H140966 H182011 Hl82202 H271519 H271828 H272033 H272195 H140096 H140213 H140730 H140789 H140847 H140909 H140967 H182012 Hl82203 H271523 H271833 H272035 H272197 H140097 H140214 H140731 H140790 H140848 H140910 H140968 Hl82013 Hl82204 H271526 H271834 H272038 H272198 Hl40098 H140215 H140732 H140791 H140849 H140911 H140969 H182014 Hl82205 H271531 H271835 H272043 H272201 H140101 H140216 H140733 H140792 H140850 H140912 H140970 Hl82015 H182206 H271534 H271836 H272045 H272202 H140103 H140217 H140734 H140793 H140851 H140913 H140971 H182016 Hl82208 H271550 H271838 H272049 H272203 H140106 H140218 Hl4073S Hl40794 H140852 H140914 H140972 H182017 H182209 H271551 H271843 H272050 H272204 Hl40107 H140219 H140736 Hl40795 Hl40853 Hl40915 H140973 H182018 H182210 H271557 H271845 H272051 H272209 H140108 H140220 H140737 Hl40796 H140854 H140916 H140974 H182019 H182211 H271569 H271853 H272052 H272216 H140109 H140221 Hl40738 H140797 H140855 H140917 H140975 H182020 H270767 H271571 H271856 H272062 H272219 Hl40111 H140222 Hl40739 Hl40798 H140856 H140918 H140976 H182021 H270794 H27157S H271858 H272064 H272220 H140113 H140223 Hl40740 Hl40799 H140857 H140919 H140977 H182022 H271031 H271587 H271862 H272066 H272223 H140114 H140224 H140742 H140800 H140858 H140920 H140978 H182023 H271041 H271588 H271866 H272069 H272226 H140115 H140225 H140743 H140801 H140859 H140921 H140979 Hl82024 H271066 H271591 H271867 H272077 H272231 H140116 H140226 H140744 H140802 H140860 H140922 H140980 H182026 H27110S H271593 H271870 H272078 H272235 H140117 H140227 H140745 H140803 H140861 H140923 Hl40981 H182027 H271157 H271594 H271872 H272079 H272236 H140118 Hl40228 H140746 H140804 H140862 Hl40924 H140982 H182028 H271158 H271600 H271879 H272081 H272237 H140119 H140229 H140747 H140805 H140863 H140925 H140983 H182030 H271159 H271602 H271881 H272085 H272239 H140121 H140230 H140748 H140806 H140864 H140926 H140984 Hl82031 H271167 H271607 H271890 H272086 H272240 H140122 H140231 H140749 H140807 H140865 H140927 H140985 H182032 H271188 H271614 H271893 H272089 H272241 H140124 H140232 H1407SO H140808 H140866 H140928 H140986 Hl82033 H271214 H271618 H27189S H272094 H272243 H140125 H140233 Hl407Sl H140809 Hl40867 H140929 H140987 H182035 H271227 H271624 H271896 H272096 H272250 H140127 H140234 H140752 H140810 Hl40868 H140930 H140988 H182036 H271242 H271626 H271903 H272111 H272259 Hl40128 H14023S Hl40753 H140811 H140869 H140931 H140989 H182037 H271258 H271628 H271905 H272115 H272260 H140129 H140236 H140754 H140812 Hl40870 H140932 H140990 H182039 H271272 H271635 H271906 H272117 H272271 H140132 H140237 H140755 H140813 Hl40871 H140933 H140991 H182040 H271276 H271640 H271918 H272118 H272277 Hl40133 H140238 Hl40756 H140814 Hl40872 H140934 H140992 H182042 H271277 H271656 H271921 H272125 H272283 H140134 H140239 H140757 H14081S H140873 H140935 H140993 H182043 H271293 H271662 H271926 H272127 H272284 H140135 H140240 H140758 H140816 H140874 H140936 H140994 H182046 H271308 H271663 H271931 H272129 H272290 H272291 H272427 H272866 H273029 H273127 H273194 H290422 H291024 H291087 H291151 H291213 H293300 H293362 H272293 H272428 H272867 H273030 H273128 H273195 H290423 H291025 H291088 H291152 H291214 H293301 H293363 H272299 H272432 H272868 H273031 H273130 H273196 H290500 H291026 H291089 H291153 H291215 H293302 H293364 H272300 H272438 H272872 H273032 H273131 H273197 H290501 H291027 H291090 H291154 H291216 H293303 H293365 H272301 H272440 H272873 H273035 H273132 H273198 H290503 H291028 H291091 H291155 H291217 H293304 H293366 H272302 H272441 H272876 H273036 H273133 H273199 H290504 H291029 H291092 H291156 H291218 H293305 H293367 H272306 H272444 H272880 H273039 H273134 H273200 H290505 H291030 H291093 H291157 H291219 H293306 H293368 H272307 H272445 H272884 H273040 H273135 H273201 H290508 H291031 H291094 H291158 H29U20 H293307 H293369 H272309 H272446 H272885 H273042 H273136 H273202 H290509 H291032 H291095 H291159 H291221 H293308 H293370 H272310 H272454 H272888 H273049 H273137 H273203 H290510 H291034 H291096 H291160 H291222 H293309 H293371 H272311 H272456 H272889 H273051 H273138 H273204 H290512 H291035 H291097 H291161 H291223 H293310 H293372 H272313 H272458 H272890 H273052 H273139 H273205 H290513 H291036 H291098 H291162 H291224 H293311 H293373 H272318 H272460 H272893 H273053 H273140 H273206 H290517 H291037 H291099 H291163 H291225 H293312 H293374 H272321 H272462 H272896 H273054 H273141 H273208 H290519 H291038 H291101 H291164 H291226 H293313 H293375 H272322 H272464 H272899 H273055 H273142 H273209 H290520 H291039 H291102 H291165 H291227 H293314 H293376 H272324 H272466 H272905 H273056 H273144 H273210 H290525 H291040 H291103 H291166 H291228 H293315 H293377 H272326 H272469 H272908 H273057 H273145 H273547 H290529 H291041 H291104 H291167 H291229 H293316 H293378 H272327 H272470 H272909 H273058 H273146 H273711 H290530 H291042 H291105 H291168 H291230 H293317 H293379 H272328 H272471 H272910 H273063 H273147 H290186 H290531 H291043 H291106 H291169 H291231 H293318 H293380 H272329 H272473 H272911 H273064 H273148 H290192 H290533 H291044 H291107 H291170 H291232 H293319 H293381 H272333 H272476 H272912 H273065 H273149 H290208 H290538 H291045 H291108 H291171 H291233 H293320 H293382 H272336 H272480 H272914 H273066 H273150 H290222 H290540 H291046 H291109 H291172 H291234 H293321 H293383 H272339 H272484 H272922 H273072 H273151 H290224 H290541 H291047 H291111 H291173 H291235 H293322 H293384 H272341 H272488 H272925 H273074 H273152 H290233 H290547 H291048 H291112 H291174 H291236 H293323 H293385 H272343 H272491 H272926 H273075 H273153 H290241 H290548 H291049 H291113 H291175 H291237 H293324 H293386 H272345 H272492 H272932 H273077 H273155 H290243 H290549 H291050 H291114 H291176 H291238 H293325 H293387 H272346 H272493 H272933 H273080 H273156 H290248 H290550 H291051 H291115 H291177 H291239 H293326 H293388 H272349 H272494 H272936 H273081 H273157 H290249 H290551 H291052 H291116 H291178 H291240 H293327 H293389 H272352 H272497 H272938 H273082 H273158 H290256 H290552 H291053 H291117 H291179 H291242 H293328 H293390 H272353 H272500 H272941 H273083 H273159 H290272 H290553 H291054 H291118 H291180 H291243 H293329 H293391 H272354 H272801 H272943 H273084 H273160 H290274 H290554 H291055 H291119 H291181 H291244 H293330 H293392 H272355 H272803 H272946 H273086 H273162 H290278 H290555 H291056 H291UO H291182 H291245 H293331 H293393 H272359 H272804 H272951 H273088 H273163 H290282 H290556 H291057 H291Ul H291183 H291246 H293332 H293394 H272360 H272805 H272953 H273089 H273164 H290285 H290557 H291058 H291U2 H291184 H291247 H293333 H293395 H272362 H272806 H272955 H273092 H273165 H290287 H290558 H291059 H291123 H291185 H291248 H293334 H293396 H272365 H272811 H272956 H273093 H273166 H290289 H290559 H291060 H291124 H291186 H291249 H293335 H293397 H272370 H272816 H272960 H273100 H273167 H290294 H290560 H291061 H291US H291187 H291250 H293336 H293398 H272372 H272820 H272961 H273101 H273168 H290295 H290561 H291062 H291U6 H291188 H291251 H293337 H293399 H272377 H272822 H272963 H273102 H273169 H290304 H290600 H291063 H291U7 H291189 H291252 H293338 H293401 H272379 H272824 H272964 H273103 H273170 H290308 H291001 H291064 H291128 H291190 H291253 H293339 H293402 H272380 H272825 H272966 H273104 H273171 H290313 H291002 H291065 H291129 H291191 H291254 H293340 H293403 H272382 H272826 H272968 H273105 H273172 H290317 H291003 H291066 H291130 H291192 H291255 H293341 H293404 H272388 H272827 H272971 H273106 H273173 H290321 H291004 H291067 H291131 H291193 H291256 H293342 H293405 H272391 H272828 H272973 H273107 H273174 H290326 H291005 H291068 H291132 H291194 H291257 H293343 H293406 H272393 H272834 H272978 H273108 H273175 H290341 H291006 H291069 H291133 H291195 H291258 H293344 H293407 H272394 H272837 H272981 H273109 H273176 H290352 H291007 H291070 H291134 H291196 H291259 H293345 H293408 H272397 H272841 H272982 H273110 H273177 H290358 H291008 H291071 H291135 H291197 H291260 H293346 H293409 H272401 H272842 H272985 H273111 H273178 H290362 H291009 H291072 H291136 H291198 H291261 H293347 H293410 H272405 H272846 H272986 H273112 H273179 H290371 H291010 H291073 H291137 H291199 H291262 H293348 H293411 H272407 H272847 H272987 H273113 H273180 H290372 H291011 H291074 H291138 H291200 H291263 H293349 H293412 H272408 H272848 H272990 H273114 H273181 H290376 H291012 H291075 H291139 H291201 H291264 H293350 H293413 H272410 H272849 H272993 H273116 H273182 H290380 H291013 H291076 H291140 H291202 H291265 H293351 H293414 H272412 H272851 H272996 H273117 H273183 H290386 H291014 H291077 H291141 H291203 H291266 H293352 H293415 H272413 H272852 H272998 H273118 H273184 H290392 H291015 H291078 H291142 H291204 H291267 H293353 H293416 H272415 H272854 H272999 H273119 H273186 H290397 H291016 H291079 H291143 H291205 H291268 H293354 H293417 H272416 H272856 H273003 H273120 H273187 H290399 H291017 H291080 H291144 H291206 H291269 H293355 H293418 H272418 H272857 H273004 H273121 H273188 H290400 H291018 H291081 H291145 H291207 H291270 H293356 H293419 H272421 H272858 H273006 H273122 H273189 H290401 H291019 H291082 H291146 H291208 H291271 H293357 H293420 H272422 H272859 H273011 H273123 H273190 H290402 H291020 H291083 H291147 H291209 H291272 H293358 H293421 H272423 H272862 H273016 H273124 H273191 H290403 H291021 H291084 H291148 H291210 H291273 H293359 H293422 H272425 H272864 H273026 H273125 H273192 H290405 H291022 H291085 H291149 H291211 H293009 H293360 H293423 H272426 H272865 H273027 H273126 H273193 H290414 H291023 H291086 H291150 H291212 H293207 H293361 H293424 H293425 H293487 H293550 H293614 H293677 H293741 H293804 H293868 H293930 H293995 H294058 H294122 H294185 H293426 H293488 H293551 H293615 H293678 H293742 H293805 H293869 H293931 H293996 H294059 H294123 H294186 H293427 H293489 H293552 H293616 H293679 H293743 H293806 H293870 H293933 H293997 H294060 H294124 H294187 H293428 H293490 H293553 H293617 H293681 H293744 H293807 H293871 H293934 H293998 H294061 H294125 H294188 H293429 H293491 H293554 H293618 H293682 H293745 H293808 H293872 H293935 H293999 H294062 H294126 H294189 H293430 H293492 H293555 H293619 H293683 H293746 H293809 H293873 H293936 H294000 H294063 H294127 H294190 H293431 H293493 H293556 H293620 H293684 H293747 H293810 H293874 H293937 H294001 H294064 H294128 H294191 H293432 H293494 H293557 H293621 H293685 H293748 H293811 H293875 H293938 H294002 H294065 H294129 H294192 H293433 H293495 H293558 H293622 H293686 H293749 H293812 H293876 H293940 H294003 H294066 H294130 H294193 H293434 H293496 H293559 H293623 H293687 H293750 H293813 H293877 H293941 H294004 H294067 H294131 H294194 H293435 H293497 H293560 H293624 H293688 H293751 H293814 H293878 H293942 H294005 H294068 H294132 H294195 H293436 H293498 H293561 H293625 H293689 H293752 H293815 H293879 H293943 H294006 H294069 H294133 H294196 H293437 H293499 H293562 H293626 H293690 H293753 H293816 H293880 H293944 H294007 H294070 H294134 H294197 H293438 H293500 H293563 H293627 H293691 H293754 H293817 H293881 H293945 H294008 H294071 H294135 H294198 H293439 H293501 H293564 H293628 H293692 H293755 H293819 H293882 H293946 H294009 H294072 H294136 H294199 H293440 H293502 H293565 H293629 H293693 H293756 H293820 H293883 H293947 H294010 H294073 H294137 H294200 H293441 H293503 H293566 H293630 H293694 H293758 H293821 H293884 H293948 H294011 H294074 H294139 H294201 H293442 H293504 H293567 H293631 H293695 H293759 H293822 H293885 H293949 H294012 H294075 H294140 H294202 H293443 H293505 H293568 H293632 H293696 H293760 H293823 H293886 H293950 H294013 H294076 H294141 H294203 H293444 H293506 H293569 H293633 H293697 H293761 H293824 H293887 H293951 H294014 H294077 H294142 H294204 H293445 H293507 H293570 H293634 H293698 H293762 H293825 H293888 H293952 H294015 H294078 H294143 H294205 H293446 H293508 H293571 H293635 H293699 H293763 H293826 H293889 H293953 H294016 H294079 H294144 H294206 H293447 H293509 H293572 H293636 H293700 H293764 H293827 H293890 H293954 H294017 H294080 H294145 H294207 H293448 H293510 H293573 H293637 H293701 H293765 H293828 H293891 H293955 H294018 H294081 H294146 H294208 H293449 H293511 H293574 H293638 H293702 H293766 H293829 H293892 H293956 H294020 H294083 H294147 H294209 H293450 H293512 H293575 H293639 H293703 H293767 H293830 H293893 H293957 H294021 H294084 H294148 H294210 H293451 H293513 H293576 H293640 H293704 H293768 H293831 H293894 H293958 H294022 H294085 H294149 H294211 H293452 H293514 H293577 H293641 H293705 H293769 H293832 H293895 H293959 H294023 H294086 H294150 H294212 H293453 H293515 H293578 H293642 H293706 H293770 H293833 H293896 H293960 H294024 H294087 H294151 H294213 H293454 H293516 H293579 H293643 H293707 H293771 H293834 H293897 H293961 H294025 H294088 H294152 H294214 H293455 H293517 H293581 H293644 H293708 H293772 H293835 H293898 H293962 H294026 H294089 H294153 H294215 H293456 H293518 H293583 H293645 H293709 H293773 H293836 H293899 H293963 H294027 H294090 H294154 H294216 H293457 H293519 H293584 H293646 H293710 H293774 H293837 H293900 H293964 H294028 H294091 H294155 H294217 H293458 H293520 H293585 H293647 H293712 H293775 H293838 H293901 H293965 H294029 H294092 H294156 H294218 H293459 H293521 H293586 H293648 H293713 H293776 H293839 H293902 H293966 H294030 H294093 H294157 H294219 H293460 H293522 H293587 H293649 H293714 H293777 H293840 H293903 H293967 H294031 H294094 H294158 H294220 H293461 H293523 H293588 H293650 H293715 H293778 H293841 H293904 H293968 H294032 H294095 H294159 H294221 H293462 H293524 H293589 H293652 H293716 H293779 H293842 H293905 H293969 H294033 H294097 H294160 H294222 H293463 H293525 H293590 H293653 H293717 H293780 H293843 H293906 H293970 H294034 H294098 H294161 H294223 H293464 H293526 H293591 H293654 H293718 H293781 H293844 H293907 H293971 H294035 H294099 H294162 H294224 H293465 H293527 H293592 H293655 H293719 H293782 H293845 H293908 H293972 H294036 H294100 H294163 H294225 H293466 H293528 H293593 H293656 H293720 H293783 H293846 H293909 H293974 H294037 H294101 H294164 H294226 H293467 H293529 H293594 H293657 H293721 H293784 H293847 H293910 H293975 H294038 H294102 H294165 H294227 H293468 H293530 H293595 H293658 H293722 H293785 H293848 H293911 H293976 H294039 H294103 H294166 H294228 H293469 H293531 H293596 H293659 H293723 H293786 H293849 H293912 H293977 H294040 H294104 H294167 H294229 H293470 H293532 H293597 H293660 H293724 H293787 H293850 H293913 H293978 H294041 H294105 H294168 H294230 H293471 H293533 H293598 H293661 H293725 H293788 H293851 H293914 H293979 H294042 H294106 H294169 H294231 H293472 H293534 H293599 H293662 H293726 H293789 H293852 H293915 H293980 H294043 H294107 H294170 H294232 H293473 H293535 H293600 H293663 H293727 H293790 H293854 H293916 H293981 H294044 H294108 H294171 H294233 H293474 H293536 H293601 H293664 H293728 H293791 H293855 H293917 H293982 H294045 H294109 H294172 H294234 H293475 H293537 H293602 H293665 H293729 H293792 H293856 H293918 H293983 H294046 H294110 H294173 H294235 H293476 H293538 H293603 H293666 H293730 H293793 H293857 H293919 H293984 H294047 H294111 H294174 H294236 H293477 H293539 H293604 H293667 H293731 H293794 H293858 H293920 H293985 H294048 H294112 H294175 H294237 H293478 H293540 H293605 H293668 H293732 H293795 H293859 H293921 H293986 H294049 H294113 H294176 H294238 H293479 H293541 H293606 H293669 H293733 H293796 H293860 H293922 H293987 H294050 H294114 H294177 H294239 H293480 H293542 H293607 H293670 H293734 H293797 H293861 H293923 H293988 H294051 H294115 H294178 H294240 H293481 H293543 H293608 H293671 H293735 H293798 H293862 H293924 H293989 H294052 H294116 H294179 H294241 H293482 H293544 H293609 H293672 H293736 H293799 H293863 H293925 H293990 H294053 H294117 H294180 H294242 H293483 H293545 H293610 H293673 H293737 H293800 H293864 H293926 H293991 H294054 H294118 H294181 H294243 H293484 H293546 H293611 H293674 H293738 H293801 H293865 H293927 H293992 H294055 H294119 H294182 H294244 H293485 H293548 H293612 H293675 H293739 H293802 H293866 H293928 H293993 H294056 H294120 H294183 H294245 H293486 H293549 H293613 H293676 H293740 H293803 H293867 H293929 H293994 H294057 H294121 H294184 H294246 H294247 H294309 H294373 H294436 H294498 H294565 H294629 H294694 H294758 H294822 H294886 H294950 H295016 H294248 H294310 H294374 H294437 H294499 H294567 H294630 H294695 H294759 H294823 H294887 H294951 H295017 H294249 H294311 H294375 H294438 H294500 H294568 H294631 H294696 H294760 H294824 H294888 H294952 H295018 H294250 H294312 H294376 H294439 H294501 H294569 H294632 H294697 H294761 H294825 H294889 H294953 H295019 H294251 H294313 H294377 H294440 H294502 H294570 H294633 H294698 H294762 H294826 H294890 H294954 H295020 H294252 H294314 H294378 H294441 H294503 H294571 H294634 H294699 H294763 H294827 H294891 H294955 H295021 H294253 H294315 H294379 H294442 H294504 H294572 H294635 H294700 H294764 H294828 H294892 H294956 H295022 H294254 H294316 H294380 H294443 H294505 H294573 H294636 H294701 H294765 H294829 H294893 H294957 H295023 H294255 H294317 H294381 H294444 H294506 H294574 H294637 H294702 H294766 H294830 H294894 H294958 H295024 H294256 H294318 H294382 H294445 H294507 H294575 H294638 H294704 H294767 H294831 H294895 H294959 H295025 H294257 H294319 H294383 H294446 H294508 H294576 H294639 H294705 H294768 H294832 H294896 H294960 H295026 H294258 H294320 H294384 H294447 H294509 H294577 H294640 H294706 H294769 H294833 H294897 H294961 H295027 H294259 H294321 H294385 H294448 H294510 H294578 H294641 H294707 H294770 H294834 H294898 H294962 H295028 H294260 H294322 H294386 H294449 H294511 H294579 H294642 H294708 H294771 H294835 H294899 H294963 H295029 H294261 H294323 H294387 H294450 H294512 H294580 H294643 H294709 H294772 H294836 H294900 H294964 H295030 H294262 H294324 H294388 H294451 H294513 H294581 H294644 H294710 H294773 H294837 H294901 H294965 H295031 H294263 H294325 H294389 H294452 H294514 H294582 H294645 H294711 H294774 H294838 H294902 H294967 H295032 H294264 H294326 H294390 H294453 H294515 H294583 H294646 H294712 H294775 H294839 H294903 H294968 H295033 H294265 H294328 H294391 H294454 H294516 H294584 H294647 H294713 H294776 H294840 H294904 H294969 H295034 H294266 H294329 H294392 H294455 H294517 H294585 H294648 H294714 H294777 H294841 H294905 H294970 H295035 H294267 H294330 H294393 H294456 H294518 H294586 H294649 H294715 H294778 H294842 H294906 H294971 H295036 H294268 H294331 H294394 H294457 H294519 H294587 H294650 H294716 H294779 H294843 H294907 H294972 H295037 H294269 H294332 H294395 H294458 H294520 H294588 H294652 H294717 H294780 H294844 H294908 H294974 H295038 H294270 H294333 H294396 H294459 H294521 H294589 H294653 H294718 H294781 H294845 H294910 H294975 H295039 H294271 H294334 H294397 H294460 H294522 H294590 H294654 H294719 H294782 H294846 H294911 H294976 H295040 H294272 H294335 H294398 H294461 H294523 H294591 H294655 H294720 H294783 H294847 H294912 H294977 H295041 H294273 H294336 H294399 H294462 H294524 H294592 H294656 H294721 H294784 H294848 H294914 H294978 H295042 H294274 H294337 H294401 H294463 H294525 H294593 H294657 H294722 H294785 H294850 H294915 H294979 H295043 H294275 H294338 H294402 H294464 H294526 H294594 H294658 H294723 H294786 H294851 H294916 H294980 H295044 H294276 H294339 H294403 H294465 H294527 H294595 H294659 H294724 H294787 H294853 H294917 H294981 H295045 H294277 H294340 H294404 H294466 H294528 H294596 H294660 H294726 H294788 H294854 H294918 H294982 H295046 H294278 H294341 H294405 H294467 H294529 H294597 H294661 H294727 H294789 H294855 H294919 H294983 H295047 H294279 H294342 H294406 H294468 H294530 H294598 H294663 H294728 H294790 H294856 H294920 H294984 H295048 H294280 H294343 H294407 H294469 H294531 H294599 H294664 H294729 H294791 H294857 H294921 H294986 H295049 H294281 H294345 H294408 H294470 H294532 H294600 H294665 H294730 H294792 H294858 H294922 H294987 H295050 H294282 H294346 H294409 H294471 H294533 H294601 H294666 H294731 H294793 H294859 H294923 H294988 H295051 H294283 H294347 H294410 H294472 H294534 H294602 H294667 H294732 H294794 H294860 H294924 H294989 H295052 H294284 H294348 H294411 H294473 H294535 H294603 H294668 H294733 H294795 H294861 H294925 H294990 H295053 H294285 H294349 H294412 H294474 H294536 H294604 H294669 H294734 H294796 H294862 H294926 H294991 H295054 H294286 H294350 H294413 H294475 H294537 H294605 H294670 H294735 H294797 H294863 H294927 H294992 H295056 H294287 H294351 H294414 H294476 H294538 H294606 H294671 H294736 H294798 H294864 H294928 H294993 H295057 H294288 H294352 H294415 H294477 H294539 H294607 H294672 H294737 H294799 H294865 H294929 H294995 H295058 H294289 H294353 H294416 H294478 H294540 H294608 H294674 H294738 H294800 H294866 H294930 H294996 H295059 H294290 H294354 H294417 H294479 H294541 H294610 H294675 H294739 H294801 H294867 H294931 H294997 H295060 H294291 H294355 H294418 H294480 H294542 H294611 H294676 H294740 H294802 H294868 H294932 H294998 H295061 H294292 H294356 H294419 H294481 H294543 H294612 H294677 H294741 H294803 H294869 H294933 H294999 H295062 H294293 H294357 H294420 H294482 H294544 H294613 H294678 H294742 H294804 H294870 H294934 H295000 H295063 H294294 H294358 H294421 H294483 H294545 H294614 H294679 H294743 H294806 H294871 H294935 H295001 H295064 H294295 H294359 H294422 H294484 H294546 H294615 H294680 H294744 H294807 H294872 H294936 H295002 H295065 H294296 H294360 H294423 H294485 H294547 H294616 H294681 H294745 H294808 H294873 H294937 H295003 H295066 H294297 H294361 H294424 H294486 H294548 H294617 H294682 H294746 H294809 H294874 H294938 H295004 H295067 H294298 H294362 H294425 H294487 H294549 H294618 H294683 H294747 H294810 H294875 H294939 H295005 H295068 H294299 H294363 H294426 H294488 H294550 H294619 H294684 H294748 H294811 H294876 H294940 H295006 H295069 H294300 H294364 H294427 H294489 H294551 H294620 H294685 H294749 H294812 H294877 H294941 H295007 H295070 H294301 H294365 H294428 H294490 H294552 H294621 H294686 H294750 H294813 H294878 H294942 H295008 H295071 H294302 H294366 H294429 H294491 H294553 H294622 H294687 H294751 H294814 H294879 H294943 H295009 H295072 H294303 H294367 H294430 H294492 H294554 H294623 H294688 H294752 H294815 H294880 H294944 H295010 H295073 H294304 H294368 H294431 H294493 H294555 H294624 H294689 H294753 H294816 H294881 H294945 H295011 H295074 H294305 H294369 H294432 H294494 H294556 H294625 H294690 H294754 H294817 H294882 H294946 H295012 H295075 H294306 H294370 H294433 H294495 H294557 H294626 H294691 H294755 H294818 H294883 H294947 H295013 H295076 H294307 H294371 H294434 H294496 H294560 H294627 H294692 H294756 H294820 H294884 H294948 H295014 H295077 H294308 H294372 H294435 H294497 H294564 H294628 H294693 H294757 H294821 H294885 H294949 H295015 H295078 H295079 H295145 H295213 H295284 H295358 H295430 H295496 H295572 H295649 H295739 HCXS411 H295080 H295146 H295214 H295285 H295359 H295431 H295498 H295573 H295650 H295744 HCXS413 H295081 H295147 H295215 H295286 H295360 H295433 H295499 H295575 H295651 H295745 HCXS418 H295082 H295148 H295216 H295287 H295361 H295434 H29SSOO H295576 H295652 H295750 HCXS432 H295083 H295149 H295217 H295288 H295362 H295435 H295501 H295577 H295653 H2957SS HCXS480 H295084 H295150 H295218 H295289 H295363 H295436 H295502 H295578 H295654 H295758 HCXS483 H295085 H295151 H295219 H295290 H295366 H295437 H295503 H295579 H2956SS H295772 HCXSS18 H295086 H295152 H295220 H295291 H295367 H295438 H295504 H295580 H295656 H295782 HCXSS26 H295087 H295153 H295221 H295292 H295368 H295439 H29SSOS H295581 H295657 H295783 HCXSS44 H295089 H295154 H295222 H295293 H295369 H295440 H295506 H295582 H295658 H295784 HCXSS46 H295090 H295155 H295223 H295294 H295370 H295441 H295507 H295583 H295659 H295787 HCXS562 H295091 H295156 H295224 H295295 H295371 H295442 H295508 H295584 H295661 H295793 HCXSS64 H295092 H295157 H295225 H295296 H295372 H295443 H295509 H295585 H295662 H295794 HCXSS67 H295093 H295158 H295226 H295297 H295374 H295444 H295510 H295586 H295663 H295798 HCXSS74 H295094 H295159 H295227 H295298 H295375 H295445 H295511 H295587 H295664 H295799 HCX5625 H295095 H295160 H295228 H295299 H295377 H295446 H295512 H295588 H295665 H295803 HCX5640 H295096 H295161 H295229 H295300 H295378 H295447 H295513 H295589 H295666 H295805 HCXS686 H295097 H295162 H295230 H295301 H295381 H295448 H295514 H295590 H295667 H295806  H295098 H295163 H295231 H295302 H295382 H295449 H295515 H295591 H295668 H295807  H295099 H295165 H295232 H295303 H295383 H295450 H295517 H295592 H295669 H295808  H295100 H295166 H295233 H295304 H295384 H295451 H295519 H295594 H295670 H295809  H295101 H295167 H295234 H295305 H295385 H295452 H295520 H295595 H295671 HCX3582  H295102 H295168 H295235 H295306 H295386 H295453 H295521 H295596 H295672 HCX4019  H295103 H295170 H295236 H295307 H295387 H295454 H295522 H295597 H295673 HCX4138  H295105 H295171 H295237 H295308 H295388 H295455 H295523 H295600 H295674 HCX4344  H295106 H295172 H295238 H295309 H295389 H295456 H295525 H295601 H295675 HCX4400  H295107 H295173 H295239 H295310 H295390 H295457 H295527 H295602 H295677 HCX4566  H295108 H295174 H295240 H295311 H295391 H295458 H295528 H295603 H295678 HCX4662  H295109 H295175 H295241 H295312 H295392 H295459 H295529 H295604 H295679 HCX4703  H295110 H295176 H295242 H295313 H295393 H295460 H295530 H295605 H295683 HCX4725  H295111 H295177 H295244 H295314 H295394 H295461 H295531 H295606 H295684 HCX4805  H295112 H295178 H295245 H295316 H295395 H295462 H295532 H295607 H295685 HCX4849  H295114 H295179 H295246 H295317 H295396 H295463 H295533 H295608 H295687 HCX4852  H295115 H295180 H295247 H295319 H295397 H295464 H295534 H295609 H295688 HCX4909  H295116 H295181 H295248 H295320 H295398 H295465 H295535 H295610 H295689 HCX4913  H295117 H295182 H295249 H295321 H295399 H295466 H295536 H295611 H295690 HCX4973  H295118 H295183 H295250 H295322 H295400 H295467 H295537 H295613 H295692 HCX4994  H295119 H295184 H295251 H295323 H295401 H295468 H295538 H295615 H295693 HCXSOSS  H295120 H295185 H295252 H295324 H295402 H295469 H295539 H295616 H295699 HCXS088  H295121 H295186 H295253 H295325 H295403 H295470 H295540 H295618 H295702 HCX5104  H295122 H295187 H295254 H295326 H295404 H295471 H295541 H295620 H295703 HCXS113  H295123 H295188 H295255 H295330 H295405 H295472 H295542 H295621 H295704 HCXS137  H295124 H295192 H295256 H295331 H295406 H295474 H295543 H295622 H295706 HCXS164  H295125 H295193 H295262 H295332 H295407 H295475 H295545 H295623 H295707 HCXS189  H295126 H295195 H295263 H295333 H295408 H295476 H295547 H295626 H295708 HCX5190  H295127 H295196 H295264 H295334 H295410 H295477 H295548 H295627 H295709 HCXS191  H295128 H295197 H295265 H295335 H295412 H295478 H295549 H295628 H295710 HCX5194  H295129 H295198 H295266 H295336 H295414 H295479 H295551 H295629 H295711 HCXS243  H295130 H295199 H295268 H295337 H295415 H295481 H295552 H295630 H295714 HCXS267  H295131 H295200 H295269 H295338 H295416 H295482 H295553 H295631 H295718 HCX5274  H295132 H295201 H295270 H295339 H295417 H295484 H295554 H295633 H295719 HCX5283  H295133 H295202 H295271 H295342 H295419 H295485 H295555 H295634 H295720 HCXS315  H295134 H295203 H295272 H295343 H295420 H295486 H295556 H295635 H295721 HCXS329  H295135 H295204 H295273 H295345 H295421 H295487 H295557 H295639 H295722 HCXS340  H295136 H295205 H295275 H295346 H295422 H295488 H295558 H295641 H295723 HCXS341  H295138 H295206 H295276 H295350 H295423 H295489 H295559 H295642 H295724 HCXS344  H295139 H295207 H295277 H295352 H295424 H295490 H295560 H295643 H295725 HCXS348  H295140 H295208 H295278 H295353 H295425 H295491 H295565 H295644 H295726 HCXS349  H295141 H295209 H295279 H295354 H295426 H295492 H295566 H295645 H295727 HCX5351  H295142 H295210 H295280 H295355 H295427 H295493 H295568 H295646 H295728 HCXS376  H295143 H295211 H295281 H295356 H295428 H295494 H295570 H295647 H295731 HCXS380  H295144 H295212 H295282 H295357 H295429 H295495 H295571 H295648 H295738 HCX5409.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and in the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Belorussia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Uthuania, luxembourg, Macau, Macedonia, Malaysia, Martinique, Mauritania, Mexico, Moldova, Monaco, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, SriLanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Zimbabwe.
  • Product Description
    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. || Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
  • Manufacturer

Manufacturer

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