Recall of Device Recall Varian brand Cseries Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X,

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

What is this?

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

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56347
  • Event Risk Class
    Class 2
  • Event Number
    Z-0886-2011
  • Event Initiated Date
    2010-06-10
  • Event Date Posted
    2011-01-08
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2011-12-23
  • 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 GKZ
  • Reason
    The auto goto or auto setup functions in c-series version 7 software ignore the couch angle and exceed motion zone (unless a tolerance is defined by the user); it has the potential for collision with the patient on the couch.
  • Action
    Varian sent a Customer Technical Bulletin letter to all affected users on May 27, 2010, and was also posted to Varian's customer support site: http://www.MyVarian.com. The letter identified the product, the problem, and provided instructions on the recall. Customers were instructed to return the proof of notification (via completed "Proof of Notification Form or appropriate Postal system certified receipt of delivery to Varian. For questions regarding this recall call 650-483-3153.

Device

  • Model / Serial
    CODE(S):   H294145H293620 ,H271973 ,H272328 ,H293393 ,H294467 ,H293944 ,H293764 ,H293725 H140117H140734 ,H272492 ,H140070 ,H293653 ,H293998 ,H294049 ,H294199 ,H293726 H271877H293666 ,H273065 ,H272283 ,H293823 ,H293999 ,H293697 ,H294367 ,H293728 H272434H140754 ,H273130 ,H272370 ,H293529 ,H290201 ,H294103 ,H294440 ,H293698 H272828H293724 ,H273170 ,H272327 ,H293787 ,H290555 ,H293760 ,H294474 ,H293774 H272889H293817 ,H293381 ,H272329 ,H140772 ,H290553 ,H293682 ,H294496 ,H293776 H272922H140768 ,H140709 ,H272299 ,H293883 ,H290549 ,H293009 ,H294597 ,H293773 H140203H140775 ,H293411 ,H272425 ,H294113 ,H290552 ,H293942 ,H294641 ,H293829 H140204H293843 ,H293412 ,H272421 ,H294129 ,H290551 ,H293765 ,H294650 ,H293830 H291054H293847 ,H293463 ,H272407 ,H293908 ,H290559 ,H293758 ,H294699 ,H293854 H273072H140786 ,H140729 ,H272857 ,H293909 ,H293396 ,H290557 ,H291075 ,H293839 H140208H293850 ,H293499 ,H272859 ,H294134 ,H290547 ,H293770 ,H293368 ,H294073 H291098H293968 ,H293500 ,H291022 ,H294186 ,H290541 ,H294136 ,H140756 ,H294118 H291114H294022 ,H293668 ,H291011 ,H294092 ,H293365 ,H294143 ,H294034 ,H294104 H273027H293970 ,H293841 ,H291015 ,H294273 ,H293435 ,H294239 ,H294527 ,H294200 H273107H294017 ,H294164 ,H291082 ,H294204 ,H293387 ,H294185 ,H294107 ,H294203 H273102H140796 ,H140882 ,H291021 ,H294210 ,H293482 ,H294248 ,H294535 ,H294256 H291160H294065 ,H293567 ,H291016 ,H294317 ,H290554 ,H294290 ,H273048 ,H140856 H291191H294062 ,H290278 ,H291085 ,H140836 ,H293434 ,H294390 ,H273140 ,H294471 H291164H294175 ,H273187 ,H291018 ,H294364 ,H293555 ,H293766 ,H293371 ,H273150 H291165H294232 ,H293595 ,H291154 ,H294403 ,H293506 ,H294153 ,H273208 ,H293898 H291163H140819 ,H140763 ,H291166 ,H294383 ,H293569 ,H293961 ,H293305 ,H271763 H273103H294409 ,H293929 ,H291190 ,H294414 ,H273031 ,H294250 ,H293681 ,H273117 H140229H140843 ,H293958 ,H291172 ,H293906 ,H293853 ,H294422 ,H293842 ,H273182 H140234H294448 ,H293450 ,H291231 ,H294347 ,H293455 ,HCX4138 ,H293924 ,H293374 H140231H140844 ,H271159 ,H291179 ,H294585 ,H293498 ,H294011 ,H294462 ,H293601 H291212H294584 ,H271157 ,H291178 ,H294586 ,H293633 ,H294445 ,H294525 ,H293602 H140236H140865 ,H271569 ,H293307 ,H294553 ,H293477 ,H294480 ,H294532 ,H293645 H140235H294667 ,H271624 ,H291195 ,H294551 ,H293489 ,H294400 ,H294608 ,H293661 H291261H272188 ,H271662 ,H291194 ,H294674 ,H293626 ,HCX4400 ,H140096 ,H294098 H140232H272946 ,H271663 ,H291180 ,H294683 ,H293705 ,H294490 ,H140097 ,H294123 H291262H293494 ,H271941 ,H293509 ,H294684 ,H293676 ,H294488 ,H291115 ,H294296 H293422H294593 ,H271926 ,H293598 ,H294675 ,H293710 ,H294449 ,H293424 ,H294297 H293442H294594 ,H272157 ,H293549 ,H294352 ,H293907 ,H294568 ,H293444 ,H294304 H140713H293796 ,H272216 ,H140728 ,H294750 ,H293586 ,H294634 ,H140751 ,H294543 H291259H293940 ,H272159 ,H293521 ,H294751 ,H293745 ,H294611 ,H293662 ,H294461 H291260H294526 ,H272162 ,H293656 ,H294758 ,H293838 ,H294015 ,H293663 ,H294592 H293512H294502 ,H272311 ,H293654 ,H294766 ,H293978 ,H293495 ,H293650 ,H270794 H140732H293324 ,H272309 ,H293655 ,H293336 ,H293738 ,H293759 ,H293727 ,H271582 H293561H273186 ,H272310 ,H293784 ,H293337 ,H293753 ,H293761 ,H293612 ,H272277 H272372H293407 ,H294201 ,H273164 ,H294146 ,H294140 ,H294602 ,H294428 ,H293363 H272473H293474 ,H294109 ,H273162 ,H294114 ,H294133 ,H294636 ,H294460 ,H293362 H272458H140711 ,H294228 ,H273191 ,H294368 ,H140124 ,H273185 ,H140857 ,H293380 H272494H140704 ,H140822 ,H273200 ,H294356 ,H290533 ,H273036 ,H294432 ,H293410 H273011H140717 ,H294241 ,H273203 ,H294346 ,H294329 ,H273168 ,H294587 ,H293440 H140119H293578 ,H294230 ,H293321 ,H294264 ,H294433 ,H291199 ,H294647 ,H293408 H140114H140154 ,H294262 ,H273202 ,H294233 ,H292832 ,H291268 ,H294183 ,H293452 H273077H293533 ,H294242 ,H293379 ,H294357 ,H272834 ,H140715 ,H294371 ,H293430 H273080H140707 ,H294280 ,H293388 ,H140842 ,H291174 ,H293502 ,H290282 ,H140719 H273106H140742 ,H140850 ,H293378 ,H294084 ,H273172 ,H294074 ,H273064 ,H293409 H273110H140731 ,H294057 ,H293376 ,H294231 ,H290556 ,H293353 ,H140129 ,H293454 H273121H293576 ,H294529 ,H293392 ,H294274 ,H273066 ,H293947 ,H273089 ,H293312 H273126H293625 ,H294419 ,H273210 ,H294415 ,H293333 ,H294042 ,H273039 ,H293449 H273131H140740 ,H294519 ,H293464 ,H294160 ,H293304 ,H294043 ,H273042 ,H293451 H273104H293644 ,H140863 ,H293389 ,H294477 ,H273178 ,H271802 ,H273092 ,H293527 H273128H293675 ,H294581 ,H293597 ,H294310 ,H293524 ,H272195 ,H273134 ,H293523 H273147H140759 ,H294627 ,H293640 ,H294536 ,H293665 ,H272985 ,H273127 ,H293566 H273160H140748 ,H294605 ,H293686 ,H294601 ,H293844 ,H140125 ,H273122 ,H293557 H140140H293624 ,H140872 ,H293619 ,H294591 ,H293897 ,H272932 ,H290548 ,H293558 H140142H293651 ,H294646 ,H140747 ,H294545 ,H293755 ,H273113 ,H273111 ,H293623 H273177H272905 ,H140875 ,H140758 ,H294511 ,H140774 ,H273083 ,H273116 ,H293641 H273167H293779 ,H294678 ,H293530 ,H294369 ,H293946 ,H273115 ,H273119 ,H293634 H273175H293646 ,H140871 ,H293735 ,H294547 ,H293793 ,H273145 ,H273144 ,H293719 H273171H140764 ,H140887 ,H293763 ,H294548 ,H294121 ,H272964 ,H273132 ,H293720 H273165H293861 ,H294068 ,H293736 ,H294473 ,H293876 ,H293370 ,H273133 ,H293721 H273204H140766 ,H294067 ,H140760 ,H294589 ,H294124 ,H272973 ,H140138 ,H293730 H140144H140779 ,H293534 ,H293845 ,H140866 ,H293677 ,H273183 ,H273124 ,H293729 H140148H293860 ,H271370 ,H293732 ,H294645 ,H293310 ,H140724 ,H273156 ,H293762 H140146H140788 ,H271378 ,H293465 ,H294671 ,H294351 ,H140712 ,H140137 ,H293788 H140145H293918 ,H271531 ,H293955 ,H294685 ,H294387 ,H293419 ,H140141 ,H293797 H140151H293922 ,H271593 ,H293982 ,H294724 ,H294212 ,H293443 ,H273123 ,H293792 H140150H293949 ,H272137 ,H293575 ,H293643 ,H294374 ,H293491 ,H273125 ,H293799 H293351H293954 ,H272111 ,H294036 ,H293857 ,H294465 ,H140762 ,H273163 ,H140767 H293373H293963 ,H272497 ,H293917 ,H294198 ,H294618 ,H293781 ,H273194 ,H293813 H140139H140794 ,H272875 ,H293791 ,H273166 ,H294423 ,H140769 ,H291257 ,H293800 H140153H293992 ,H272909 ,H294085 ,H140862 ,H294060 ,H294100 ,H273197 ,H293809 H140708H294023 ,H273101 ,H294167 ,H294292 ,H294542 ,H294161 ,H273138 ,H293832 H293391H140798 ,H140136 ,H294119 ,H290561 ,H294515 ,H294223 ,H273193 ,H293798 H293334H294173 ,H273151 ,H294005 ,H140152 ,H294664 ,H140789 ,H273189 ,H293807 H293369H140815 ,H273174 ,H294117 ,H293585 ,H294238 ,H140841 ,H140238 ,H293816 H293815H294342 ,H293808 ,H140839 ,H291083 ,H273082 ,H273180 ,H294215 ,H294349 H293814H294334 ,H294656 ,H294335 ,H291127 ,H293306 ,H293320 ,H294229 ,H294588 H140773H140828 ,H294659 ,H140739 ,H291128 ,H273181 ,H294144 ,H294315 ,H294705 H293827H140834 ,H140873 ,H291064 ,H291141 ,H293375 ,H294205 ,H294370 ,H293618 H293828H294318 ,H294610 ,H291227 ,H291168 ,H293532 ,H294401 ,H294569 ,H271265 H293881H294309 ,H140889 ,H291044 ,H291204 ,H294080 ,H294402 ,H272033 ,H272219 H293895H294293 ,H294600 ,H291132 ,H291205 ,H294435 ,H294495 ,H273084 ,H290386 H293896H294307 ,H294693 ,H293540 ,H291223 ,H294434 ,H140886 ,H273108 ,H272405 H293920H294338 ,H294723 ,H140755 ,H293447 ,H294746 ,H291130 ,H140147 ,H272362 H293911H294363 ,H140892 ,H293959 ,H271860 ,H271881 ,H291137 ,H273179 ,H272333 H293943H294283 ,H294635 ,H293678 ,H271976 ,H272023 ,H291055 ,H273201 ,H291037 H293887H294396 ,H294643 ,H293997 ,H271681 ,H293349 ,H140135 ,H273198 ,H291238 H293812H294308 ,H294666 ,H293616 ,H140847 ,H293545 ,H291198 ,H291254 ,H291237 H140785H294450 ,H294668 ,H294097 ,H291250 ,H293801 ,H273159 ,H273184 ,H293395 H293884H294447 ,H294676 ,H294247 ,H293469 ,H140840 ,H273153 ,H273195 ,H293448 H294002H140849 ,H294700 ,H294313 ,H293468 ,H140874 ,H293421 ,H293479 ,H293394 H294027H294319 ,H294701 ,H290208 ,H294344 ,H140700 ,H293456 ,H293572 ,H293423 H294046H294451 ,H294706 ,H290274 ,HCX4344 ,H294044 ,H293364 ,H293559 ,H293604 H294152H294312 ,H294713 ,H290400 ,H140090 ,H140878 ,H293704 ,H293570 ,H293657 H140804H294407 ,H294715 ,H290399 ,H140101 ,H140803 ,H293553 ,H293390 ,H293767 H294071H294260 ,H294726 ,H272359 ,H290517 ,H273112 ,H293631 ,H293599 ,H290372 H140814H294066 ,H294728 ,H290501 ,H140121 ,H273176 ,H293628 ,H293446 ,H294037 H294154H294463 ,H294731 ,H291211 ,H140062 ,H294108 ,H293679 ,H293382 ,H294082 H294195H294503 ,H294732 ,H293596 ,H140143 ,H294190 ,H293794 ,H293383 ,H140790 H294220H294087 ,H294736 ,H293741 ,H293384 ,H294191 ,H293386 ,H140730 ,H294219 H294176H294213 ,H294737 ,H293866 ,H140705 ,H294520 ,H293471 ,H293712 ,H294681 H294165H294580 ,H293603 ,H293964 ,H293328 ,H294606 ,H293629 ,H293497 ,H294682 H294258H294583 ,H294093 ,H294331 ,H140134 ,H290256 ,H293785 ,H293849 ,H271400 H294271H294492 ,H294491 ,H140877 ,H293637 ,H271890 ,H293786 ,H293852 ,H272397 H294270H294582 ,H294279 ,H272418 ,H140745 ,H273173 ,H293870 ,H293951 ,H272427 H294276H294508 ,H294533 ,H291009 ,H140750 ,H273155 ,H294038 ,H293941 ,H290511 H294277H294590 ,H293550 ,H291103 ,H140741 ,H293372 ,H293904 ,H293972 ,H272911 H294278H294632 ,H293938 ,H293531 ,H140749 ,H293977 ,H293905 ,H294193 ,H291033 H294289H294339 ,H294489 ,H140752 ,H294070 ,H294055 ,H293510 ,H294192 ,H290540 H294216H294094 ,H290262 ,H293574 ,H294072 ,H140743 ,H293869 ,H294208 ,H291213 H294217H294637 ,H290263 ,H293996 ,H140805 ,H140771 ,H294047 ,H294211 ,H291232 H294281H294537 ,H290352 ,H294081 ,H294069 ,H294214 ,H294059 ,H294389 ,H293577 H294272H294649 ,H291046 ,H294523 ,H140859 ,H294779 ,H140818 ,H294014 ,H293593 H294306H294619 ,H293630 ,H290423 ,H140861 ,H294565 ,H293878 ,H293990 ,H293492 H294288H294663 ,H140823 ,H291007 ,H291059 ,H273142 ,H294147 ,H293991 ,H293649 H293667H293511 ,H272908 ,H294102 ,H290249 ,H140001 ,H272014 ,H140046 ,H272401 H293742H293339 ,H273004 ,H294076 ,H271393 ,H271760 ,H290362 ,H272238 ,H272394 H293652H290560 ,H273049 ,H294077 ,H271407 ,H271762 ,H272009 ,H272237 ,H272801 H293818H294639 ,H272469 ,H294078 ,H271413 ,H271785 ,H271975 ,H272236 ,H272456 H293834H294640 ,H273063 ,H294079 ,H271385 ,H271780 ,H271964 ,H272259 ,H272470 H293778H291233 ,H273105 ,H294218 ,H271439 ,H271797 ,H272052 ,H290392 ,H272500 H293914H293879 ,H291152 ,H293867 ,H271452 ,H271835 ,H272000 ,H272271 ,H272803 H293928H273149 ,H291151 ,H294257 ,H271438 ,H271838 ,H272043 ,H140058 ,H272454 H293965H273152 ,H140224 ,H294354 ,H271425 ,H271831 ,H272035 ,H272301 ,H272466 H293981H293323 ,H140225 ,H294263 ,H271502 ,H271783 ,H140038 ,H272306 ,H272479 H293993H273114 ,H140226 ,H294323 ,H271515 ,H271858 ,H272045 ,H290397 ,H272491 H140797H293315 ,H140227 ,H294321 ,H271519 ,H271856 ,H271951 ,H272307 ,H140088 H294305H293584 ,H291271 ,H294320 ,H271526 ,H271862 ,H272049 ,H272291 ,H272480 H140864H293739 ,H273206 ,H294322 ,H271507 ,H271833 ,H290376 ,H272321 ,H140092 H273143H293803 ,H293325 ,H294268 ,H271523 ,H140011 ,H271942 ,H272325 ,H140201 H271994H293687 ,H293326 ,H294539 ,H290287 ,H271879 ,H272062 ,H272293 ,H290505 H291008H293795 ,H293207 ,H294541 ,H271497 ,H271825 ,H272069 ,H272326 ,H272816 H291182H293865 ,H293356 ,H294171 ,H271559 ,H271870 ,H272001 ,H272302 ,H290503 H291108H294110 ,H293327 ,H294540 ,H271587 ,H271893 ,H272086 ,H272346 ,H272476 H293311H294111 ,H293416 ,H294538 ,H271588 ,H271896 ,H272078 ,H290405 ,H272811 H293331H294040 ,H293417 ,H294621 ,H271420 ,H271900 ,H272089 ,H272345 ,H290509 H293556H293301 ,H293377 ,H294620 ,H271594 ,H290341 ,H140043 ,H140073 ,H272837 H293507H293314 ,H273055 ,H294716 ,H271607 ,H271903 ,H290371 ,H290402 ,H272822 H293747H294345 ,H293441 ,H140893 ,H271626 ,H140018 ,H272081 ,H140071 ,H272824 H140795H294412 ,H293583 ,H270788 ,H271669 ,H271921 ,H272129 ,H272336 ,H272488 H293740H294411 ,H293674 ,H271041 ,H271664 ,H290326 ,H272134 ,H140067 ,H272854 H293980H294379 ,H293671 ,H270862 ,H290304 ,H271906 ,H140045 ,H272354 ,H272860 H293872H294438 ,H293672 ,H271066 ,H271691 ,H271918 ,H272143 ,H272365 ,H140098 H293875H294439 ,H293670 ,H271105 ,H290313 ,H271895 ,H272172 ,H272341 ,H272841 H293960H294388 ,H293716 ,H271169 ,H290308 ,H271935 ,H272187 ,H272355 ,H272862 H140829H294644 ,H293715 ,H290241 ,H271678 ,H271966 ,H272178 ,H272377 ,H290510 H291272H273056 ,H293717 ,H271167 ,H271618 ,H140026 ,H290379 ,H140076 ,H272873 H293496H293752 ,H293718 ,H271242 ,H140020 ,H140027 ,H272202 ,H272388 ,H290508 H293600H294255 ,H293669 ,H290222 ,H271711 ,H140031 ,H272174 ,H272410 ,H272866 H293638H293751 ,H293804 ,H271362 ,H271693 ,H271993 ,H272209 ,H272422 ,H272868 H293848H273148 ,H293820 ,H271194 ,H271712 ,H271961 ,H272220 ,H272428 ,H272872 H294141H294657 ,H293782 ,H271308 ,H271720 ,H271974 ,H272204 ,H140078 ,H272847 H294265H271954 ,H293826 ,H290224 ,H271729 ,H140025 ,H140047 ,H140077 ,H272885 H294284H271872 ,H293713 ,H271334 ,H271714 ,H272029 ,H272231 ,H272426 ,H272914 H290550H272826 ,H293714 ,H290243 ,H271724 ,H272003 ,H272223 ,H272444 ,H291002 H290600H273029 ,H291076 ,H291048 ,H273135 ,H291219 ,H293303 ,H293318 ,H293432 H272893H291028 ,H291077 ,H291088 ,H291140 ,H140233 ,H291236 ,H293357 ,H293425 H290520H273030 ,H291052 ,H140211 ,H291045 ,H291202 ,H293332 ,H291229 ,H293300 H291006H291032 ,H291079 ,H291099 ,H291109 ,H291169 ,H291266 ,H291249 ,H293438 H140109H272971 ,H272978 ,H140215 ,H291117 ,H291200 ,H291247 ,H140149 ,H140706 H272899H291027 ,H291073 ,H140133 ,H291111 ,H291218 ,H291256 ,H293313 ,H293366 H291001H291025 ,H291067 ,H291120 ,H291116 ,H291170 ,H291270 ,H291252 ,H293404 H291004H291026 ,H291078 ,H291136 ,H291157 ,H291196 ,H291253 ,H140703 ,H293348 H272926H291038 ,H291063 ,H140219 ,H291161 ,H291221 ,H293316 ,H293345 ,H293486 H272938H273016 ,H140216 ,H273120 ,H291113 ,H291222 ,H140240 ,H293429 ,H293397 H290519H272982 ,H140213 ,H273109 ,H140220 ,H291207 ,H293308 ,H293431 ,H293490 H291003H291023 ,H291090 ,H291149 ,H291092 ,H291209 ,H293322 ,H293385 ,H293503 H140111H272990 ,H291068 ,H291134 ,H273137 ,H140228 ,H291224 ,H293426 ,H291176 H140202H291029 ,H291074 ,H291096 ,H273136 ,H291133 ,H291243 ,H293342 ,H293439 H272960H291020 ,H140217 ,H291139 ,H291162 ,H291181 ,H291225 ,H293360 ,H293508 H272981H291042 ,H273026 ,H273118 ,H291183 ,H291171 ,H291267 ,H293418 ,H293485 H272842H272825 ,H291072 ,H291142 ,H291150 ,H291185 ,H291245 ,H293428 ,H293518 H291013H291035 ,H291080 ,H291094 ,H291131 ,H291216 ,H291258 ,H293414 ,H293406 H291005H291039 ,H291097 ,H140218 ,H291053 ,H291203 ,H291255 ,H291226 ,H293354 H140205H291043 ,H291093 ,H140221 ,H140223 ,H291210 ,H290558 ,H291248 ,H293459 H291010H272987 ,H291100 ,H291101 ,H273158 ,H273199 ,H293343 ,H291263 ,H293476 H272846H140207 ,H291105 ,H291146 ,H291159 ,H291208 ,H293358 ,H293436 ,H140720 H272848H291041 ,H291066 ,H140222 ,H291135 ,H291234 ,H293329 ,H293403 ,H293466 H290504H291049 ,H291069 ,H140209 ,H291186 ,H291235 ,H293340 ,H293460 ,H293483 H290512H273052 ,H291081 ,H291119 ,H291192 ,H291215 ,H293335 ,H293413 ,H293405 H272956H273040 ,H291061 ,H291123 ,H291184 ,H291220 ,H293350 ,H140239 ,H293488 H272963H291050 ,H273075 ,H291129 ,H291187 ,H291206 ,H293309 ,H293402 ,H293420 H272993H291056 ,H140214 ,H291121 ,H291144 ,H291241 ,H293346 ,H293472 ,H293433 H272999H291065 ,H140206 ,H291122 ,H291143 ,H140237 ,H291230 ,H293398 ,H293484 H291024H140212 ,H291106 ,H291112 ,H291167 ,H291175 ,H293352 ,H140714 ,H140722 H291012H291057 ,H291102 ,H291145 ,H291158 ,H291217 ,H293302 ,H293453 ,H293401 H272986H291058 ,H291084 ,H273141 ,H291177 ,H291264 ,H291240 ,H293445 ,H293541 H291019H291070 ,H291086 ,H291153 ,H273157 ,H273190 ,H293361 ,H293437 ,H293548 H140115H291071 ,H291087 ,H291118 ,H291148 ,H273209 ,H291269 ,H293427 ,H293344 H291017H273053 ,H291089 ,H291155 ,H291188 ,H291242 ,H291251 ,H293457 ,H293480 H291014H291047 ,H291107 ,H291125 ,H291197 ,H291173 ,H293317 ,H140716 ,H293481 H291030H291051 ,H272996 ,H291126 ,H140230 ,H291246 ,H293330 ,H293461 ,H293478 H291034H291062 ,H291104 ,H291138 ,H291189 ,H291214 ,H291239 ,H293462 ,H293536 H290530H291031 ,H291040 ,H291147 ,H291193 ,H291273 ,H291265 ,H293355 ,H293581 H291036H291060 ,H140210 ,H291156 ,H291124 ,H291228 ,H293399 ,H293415 ,H293319 H293501H293591 ,H293673 ,H293695 ,H293873 ,H293919 ,H294032 ,H140806 ,H294184 H293517H293562 ,H293690 ,H140733 ,H293891 ,H140791 ,H294045 ,H294105 ,H294166 H293519H293504 ,H293587 ,H293771 ,H293890 ,H293926 ,H294030 ,H294112 ,H294178 H293473H293590 ,H293689 ,H293756 ,H293880 ,H293932 ,H294006 ,H294053 ,H294209 H293458H293592 ,H293706 ,H140736 ,H293855 ,H293925 ,H294033 ,H293986 ,H140813 H293367H293538 ,H293647 ,H293611 ,H293868 ,H293948 ,H294041 ,H294125 ,H294194 H293568H293608 ,H293700 ,H293783 ,H140780 ,H293956 ,H294051 ,H140807 ,H294234 H293564H293539 ,H293696 ,H293790 ,H293877 ,H293930 ,H294026 ,H140808 ,H294227 H293579H140701 ,H293694 ,H293750 ,H293885 ,H140793 ,H294048 ,H140810 ,H294207 H293475H293610 ,H293554 ,H293806 ,H293864 ,H293962 ,H294039 ,H294130 ,H294116 H291095H140746 ,H293702 ,H140765 ,H293882 ,H293966 ,H293974 ,H294095 ,H294101 H293359H140718 ,H293692 ,H293708 ,H140784 ,H293899 ,H293994 ,H294106 ,H294197 H293544H140735 ,H293693 ,H293658 ,H293701 ,H293967 ,H294004 ,H294122 ,H294181 H293552H293522 ,H293699 ,H293769 ,H293862 ,H293936 ,H294031 ,H294142 ,H294196 H293565H293543 ,H293703 ,H293821 ,H293913 ,H293953 ,H294008 ,H294132 ,H294188 H293589H293594 ,H293746 ,H293819 ,H140770 ,H293971 ,H294063 ,H294157 ,H294237 H293347H293505 ,H291201 ,H293824 ,H293888 ,H293957 ,H294003 ,H294151 ,H294131 H293487H293642 ,H293733 ,H140776 ,H293902 ,H293934 ,H293984 ,H294099 ,H294202 H293514H293648 ,H140757 ,H293789 ,H293900 ,H293950 ,H294024 ,H294054 ,H294225 H293516H293588 ,H293709 ,H293825 ,H140783 ,H293969 ,H294028 ,H294135 ,H294029 H293467H293606 ,H293734 ,H293754 ,H293886 ,H293995 ,H294025 ,H140809 ,H294148 H293513H293537 ,H293685 ,H293802 ,H293910 ,H293975 ,H294061 ,H294137 ,H294162 H293515H293520 ,H293535 ,H293573 ,H293912 ,H293987 ,H294052 ,H140811 ,H294163 H293546H293551 ,H293659 ,H293805 ,H293889 ,H140782 ,H294050 ,H294156 ,H294240 H293614H293621 ,H293707 ,H293836 ,H293874 ,H293952 ,H294056 ,H294159 ,H294243 H140725H293622 ,H293743 ,H293822 ,H293893 ,H293988 ,H293983 ,H294168 ,H140821 H293525H293660 ,H293723 ,H293846 ,H293903 ,H293985 ,H294086 ,H294058 ,H294244 H293617H293639 ,H291244 ,H140778 ,H293915 ,H293921 ,H140799 ,H294179 ,H294252 H140721H140738 ,H293744 ,H140777 ,H293935 ,H294009 ,H294088 ,H140801 ,H294149 H140726H293636 ,H293748 ,H293856 ,H140787 ,H293979 ,H294075 ,H294169 ,H294126 H140727H293607 ,H140753 ,H293831 ,H293772 ,H294010 ,H294064 ,H294172 ,H294127 H273196H293571 ,H140761 ,H293851 ,H293931 ,H294021 ,H294000 ,H294155 ,H294128 H293615H293683 ,H293737 ,H293840 ,H293894 ,H293989 ,H294089 ,H294177 ,H294245 H140723H293563 ,H293341 ,H293859 ,H293923 ,H293976 ,H294091 ,H294187 ,H294254 H293609H140710 ,H140737 ,H293835 ,H293901 ,H294016 ,H294120 ,H140800 ,H294269 H293560H293684 ,H293749 ,H293863 ,H293892 ,H294012 ,H140802 ,H140817 ,H140820 H293470H293493 ,H293688 ,H293664 ,H140781 ,H294018 ,H294007 ,H294182 ,H294267 H293635H293613 ,H293780 ,H293858 ,H293916 ,H294013 ,H294083 ,H294170 ,H294226 H293627H293691 ,H293775 ,H293837 ,H293933 ,H294001 ,H294035 ,H294189 ,H294266 H140744H293605 ,H293777 ,H293871 ,H140792 ,H294020 ,H294090 ,H294180 ,H294285 H294261H294360 ,H294397 ,H294521 ,H294572 ,H140883 ,H294282 ,H294394 ,H293833 H140825H294158 ,H294421 ,H294443 ,H294577 ,H294698 ,H294294 ,H294365 ,H294486 H294275H294326 ,H294427 ,H294509 ,H294458 ,H294660 ,H294328 ,H294393 ,H294475 H294150H294366 ,H294425 ,H294406 ,H294507 ,H294679 ,H294324 ,H294381 ,H294430 H294235H294358 ,H294429 ,H294530 ,H294571 ,H294696 ,H294325 ,H294380 ,H294479 H140824H140838 ,H140848 ,H294534 ,H294574 ,H294711 ,H140831 ,H294395 ,H294494 H140827H294246 ,H294436 ,H294517 ,H294236 ,H294720 ,H294336 ,H294399 ,H294418 H294287H294333 ,H294437 ,H294470 ,H294598 ,H294719 ,H140832 ,H294362 ,H294478 H294286H294355 ,H294424 ,H294510 ,H140855 ,H294712 ,H294332 ,H294372 ,H294482 H294295H294361 ,H294426 ,H294513 ,H294603 ,H294677 ,H294348 ,H294398 ,H294504 H294224H294373 ,H294469 ,H294516 ,H294604 ,H294686 ,H294350 ,H294420 ,H294485 H294299H294340 ,H140851 ,H294524 ,H294616 ,H140897 ,H294353 ,H294408 ,H294481 H294298H294392 ,H294444 ,H294441 ,H140816 ,H294738 ,H294341 ,H294385 ,H294499 H294301H294376 ,H294468 ,H294544 ,H294599 ,H294735 ,H140833 ,H140846 ,H294483 H294316H294174 ,H140852 ,H294528 ,H294595 ,H294729 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  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, TX, IL, GA, NJ, and NV and the countries of Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Middle East, Netherlands, Russia, Spain, Switzerland, and the UK
  • Product Description
    Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extra cranial and consist of single-session or fractionated delivery.
  • Manufacturer

Manufacturer

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