Class 2 Device Recall Varian brand Cseries Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X,

• Date Initiated by Firm: June 10, 2010
• Date Posted: January 08, 2011
• Recall Status: Terminated on December 23, 2011
• Recall Number: Z-0886-2011
• Recall Event ID: 56347
• 510(K)Number: K904364 K913119 K070094
• Product Classification: Accelerator, linear, medical - Product Code GKZ
• Product: 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.
• Code Information: CODE(S): H294145; ; H293620 ,H271973 ,H272328 ,H293393 ,H294467 ,H293944 ,H293764 ,H293725 H140117; ; H140734 ,H272492 ,H140070 ,H293653 ,H293998 ,H294049 ,H294199 ,H293726 H271877; ; H293666 ,H273065 ,H272283 ,H293823 ,H293999 ,H293697 ,H294367 ,H293728 H272434; ; H140754 ,H273130 ,H272370 ,H293529 ,H290201 ,H294103 ,H294440 ,H293698 H272828; ; H293724 ,H273170 ,H272327 ,H293787 ,H290555 ,H293760 ,H294474 ,H293774 H272889; ; H293817 ,H293381 ,H272329 ,H140772 ,H290553 ,H293682 ,H294496 ,H293776 H272922; ; H140768 ,H140709 ,H272299 ,H293883 ,H290549 ,H293009 ,H294597 ,H293773 H140203; ; H140775 ,H293411 ,H272425 ,H294113 ,H290552 ,H293942 ,H294641 ,H293829 H140204; ; H293843 ,H293412 ,H272421 ,H294129 ,H290551 ,H293765 ,H294650 ,H293830 H291054; ; H293847 ,H293463 ,H272407 ,H293908 ,H290559 ,H293758 ,H294699 ,H293854 H273072; ; H140786 ,H140729 ,H272857 ,H293909 ,H293396 ,H290557 ,H291075 ,H293839 H140208; ; H293850 ,H293499 ,H272859 ,H294134 ,H290547 ,H293770 ,H293368 ,H294073 H291098; ; H293968 ,H293500 ,H291022 ,H294186 ,H290541 ,H294136 ,H140756 ,H294118 H291114; ; H294022 ,H293668 ,H291011 ,H294092 ,H293365 ,H294143 ,H294034 ,H294104 H273027; ; H293970 ,H293841 ,H291015 ,H294273 ,H293435 ,H294239 ,H294527 ,H294200 H273107; ; H294017 ,H294164 ,H291082 ,H294204 ,H293387 ,H294185 ,H294107 ,H294203 H273102; ; H140796 ,H140882 ,H291021 ,H294210 ,H293482 ,H294248 ,H294535 ,H294256 H291160; ; H294065 ,H293567 ,H291016 ,H294317 ,H290554 ,H294290 ,H273048 ,H140856 H291191; ; H294062 ,H290278 ,H291085 ,H140836 ,H293434 ,H294390 ,H273140 ,H294471 H291164; ; H294175 ,H273187 ,H291018 ,H294364 ,H293555 ,H293766 ,H293371 ,H273150 H291165; ; H294232 ,H293595 ,H291154 ,H294403 ,H293506 ,H294153 ,H273208 ,H293898 H291163; ; H140819 ,H140763 ,H291166 ,H294383 ,H293569 ,H293961 ,H293305 ,H271763 H273103; ; H294409 ,H293929 ,H291190 ,H294414 ,H273031 ,H294250 ,H293681 ,H273117 H140229; ; H140843 ,H293958 ,H291172 ,H293906 ,H293853 ,H294422 ,H293842 ,H273182 H140234; ; H294448 ,H293450 ,H291231 ,H294347 ,H293455 ,HCX4138 ,H293924 ,H293374 H140231; ; H140844 ,H271159 ,H291179 ,H294585 ,H293498 ,H294011 ,H294462 ,H293601 H291212; ; H294584 ,H271157 ,H291178 ,H294586 ,H293633 ,H294445 ,H294525 ,H293602 H140236; ; H140865 ,H271569 ,H293307 ,H294553 ,H293477 ,H294480 ,H294532 ,H293645 H140235; ; H294667 ,H271624 ,H291195 ,H294551 ,H293489 ,H294400 ,H294608 ,H293661 H291261; ; H272188 ,H271662 ,H291194 ,H294674 ,H293626 ,HCX4400 ,H140096 ,H294098 H140232; ; H272946 ,H271663 ,H291180 ,H294683 ,H293705 ,H294490 ,H140097 ,H294123 H291262; ; H293494 ,H271941 ,H293509 ,H294684 ,H293676 ,H294488 ,H291115 ,H294296 H293422; ; H294593 ,H271926 ,H293598 ,H294675 ,H293710 ,H294449 ,H293424 ,H294297 H293442; ; H294594 ,H272157 ,H293549 ,H294352 ,H293907 ,H294568 ,H293444 ,H294304 H140713; ; H293796 ,H272216 ,H140728 ,H294750 ,H293586 ,H294634 ,H140751 ,H294543 H291259; ; H293940 ,H272159 ,H293521 ,H294751 ,H293745 ,H294611 ,H293662 ,H294461 H291260; ; H294526 ,H272162 ,H293656 ,H294758 ,H293838 ,H294015 ,H293663 ,H294592 H293512; ; H294502 ,H272311 ,H293654 ,H294766 ,H293978 ,H293495 ,H293650 ,H270794 H140732; ; H293324 ,H272309 ,H293655 ,H293336 ,H293738 ,H293759 ,H293727 ,H271582 H293561; ; H273186 ,H272310 ,H293784 ,H293337 ,H293753 ,H293761 ,H293612 ,H272277 H272372; ; H293407 ,H294201 ,H273164 ,H294146 ,H294140 ,H294602 ,H294428 ,H293363 H272473; ; H293474 ,H294109 ,H273162 ,H294114 ,H294133 ,H294636 ,H294460 ,H293362 H272458; ; H140711 ,H294228 ,H273191 ,H294368 ,H140124 ,H273185 ,H140857 ,H293380 H272494; ; H140704 ,H140822 ,H273200 ,H294356 ,H290533 ,H273036 ,H294432 ,H293410 H273011; ; H140717 ,H294241 ,H273203 ,H294346 ,H294329 ,H273168 ,H294587 ,H293440 H140119; ; H293578 ,H294230 ,H293321 ,H294264 ,H294433 ,H291199 ,H294647 ,H293408 H140114; ; H140154 ,H294262 ,H273202 ,H294233 ,H292832 ,H291268 ,H294183 ,H293452 H273077; ; H293533 ,H294242 ,H293379 ,H294357 ,H272834 ,H140715 ,H294371 ,H293430 H273080; ; H140707 ,H294280 ,H293388 ,H140842 ,H291174 ,H293502 ,H290282 ,H140719 H273106; ; H140742 ,H140850 ,H293378 ,H294084 ,H273172 ,H294074 ,H273064 ,H293409 H273110; ; H140731 ,H294057 ,H293376 ,H294231 ,H290556 ,H293353 ,H140129 ,H293454 H273121; ; H293576 ,H294529 ,H293392 ,H294274 ,H273066 ,H293947 ,H273089 ,H293312 H273126; ; H293625 ,H294419 ,H273210 ,H294415 ,H293333 ,H294042 ,H273039 ,H293449 H273131; ; H140740 ,H294519 ,H293464 ,H294160 ,H293304 ,H294043 ,H273042 ,H293451 H273104; ; H293644 ,H140863 ,H293389 ,H294477 ,H273178 ,H271802 ,H273092 ,H293527 H273128; ; H293675 ,H294581 ,H293597 ,H294310 ,H293524 ,H272195 ,H273134 ,H293523 H273147; ; H140759 ,H294627 ,H293640 ,H294536 ,H293665 ,H272985 ,H273127 ,H293566 H273160; ; H140748 ,H294605 ,H293686 ,H294601 ,H293844 ,H140125 ,H273122 ,H293557 H140140; ; H293624 ,H140872 ,H293619 ,H294591 ,H293897 ,H272932 ,H290548 ,H293558 H140142; ; H293651 ,H294646 ,H140747 ,H294545 ,H293755 ,H273113 ,H273111 ,H293623 H273177; ; H272905 ,H140875 ,H140758 ,H294511 ,H140774 ,H273083 ,H273116 ,H293641 H273167; ; H293779 ,H294678 ,H293530 ,H294369 ,H293946 ,H273115 ,H273119 ,H293634 H273175; ; H293646 ,H140871 ,H293735 ,H294547 ,H293793 ,H273145 ,H273144 ,H293719 H273171; ; H140764 ,H140887 ,H293763 ,H294548 ,H294121 ,H272964 ,H273132 ,H293720 H273165; ; H293861 ,H294068 ,H293736 ,H294473 ,H293876 ,H293370 ,H273133 ,H293721 H273204; ; H140766 ,H294067 ,H140760 ,H294589 ,H294124 ,H272973 ,H140138 ,H293730 H140144; ; H140779 ,H293534 ,H293845 ,H140866 ,H293677 ,H273183 ,H273124 ,H293729 H140148; ; H293860 ,H271370 ,H293732 ,H294645 ,H293310 ,H140724 ,H273156 ,H293762 H140146; ; H140788 ,H271378 ,H293465 ,H294671 ,H294351 ,H140712 ,H140137 ,H293788 H140145; ; H293918 ,H271531 ,H293955 ,H294685 ,H294387 ,H293419 ,H140141 ,H293797 H140151; ; H293922 ,H271593 ,H293982 ,H294724 ,H294212 ,H293443 ,H273123 ,H293792 H140150; ; H293949 ,H272137 ,H293575 ,H293643 ,H294374 ,H293491 ,H273125 ,H293799 H293351; ; H293954 ,H272111 ,H294036 ,H293857 ,H294465 ,H140762 ,H273163 ,H140767 H293373; ; H293963 ,H272497 ,H293917 ,H294198 ,H294618 ,H293781 ,H273194 ,H293813 H140139; ; H140794 ,H272875 ,H293791 ,H273166 ,H294423 ,H140769 ,H291257 ,H293800 H140153; ; H293992 ,H272909 ,H294085 ,H140862 ,H294060 ,H294100 ,H273197 ,H293809 H140708; ; H294023 ,H273101 ,H294167 ,H294292 ,H294542 ,H294161 ,H273138 ,H293832 H293391; ; H140798 ,H140136 ,H294119 ,H290561 ,H294515 ,H294223 ,H273193 ,H293798 H293334; ; H294173 ,H273151 ,H294005 ,H140152 ,H294664 ,H140789 ,H273189 ,H293807 H293369; ; H140815 ,H273174 ,H294117 ,H293585 ,H294238 ,H140841 ,H140238 ,H293816 H293815; ; H294342 ,H293808 ,H140839 ,H291083 ,H273082 ,H273180 ,H294215 ,H294349 H293814; ; H294334 ,H294656 ,H294335 ,H291127 ,H293306 ,H293320 ,H294229 ,H294588 H140773; ; H140828 ,H294659 ,H140739 ,H291128 ,H273181 ,H294144 ,H294315 ,H294705 H293827; ; H140834 ,H140873 ,H291064 ,H291141 ,H293375 ,H294205 ,H294370 ,H293618 H293828; ; H294318 ,H294610 ,H291227 ,H291168 ,H293532 ,H294401 ,H294569 ,H271265 H293881; ; H294309 ,H140889 ,H291044 ,H291204 ,H294080 ,H294402 ,H272033 ,H272219 H293895; ; H294293 ,H294600 ,H291132 ,H291205 ,H294435 ,H294495 ,H273084 ,H290386 H293896; ; H294307 ,H294693 ,H293540 ,H291223 ,H294434 ,H140886 ,H273108 ,H272405 H293920; ; H294338 ,H294723 ,H140755 ,H293447 ,H294746 ,H291130 ,H140147 ,H272362 H293911; ; H294363 ,H140892 ,H293959 ,H271860 ,H271881 ,H291137 ,H273179 ,H272333 H293943; ; H294283 ,H294635 ,H293678 ,H271976 ,H272023 ,H291055 ,H273201 ,H291037 H293887; ; H294396 ,H294643 ,H293997 ,H271681 ,H293349 ,H140135 ,H273198 ,H291238 H293812; ; H294308 ,H294666 ,H293616 ,H140847 ,H293545 ,H291198 ,H291254 ,H291237 H140785; ; H294450 ,H294668 ,H294097 ,H291250 ,H293801 ,H273159 ,H273184 ,H293395 H293884; ; H294447 ,H294676 ,H294247 ,H293469 ,H140840 ,H273153 ,H273195 ,H293448 H294002; ; H140849 ,H294700 ,H294313 ,H293468 ,H140874 ,H293421 ,H293479 ,H293394 H294027; ; H294319 ,H294701 ,H290208 ,H294344 ,H140700 ,H293456 ,H293572 ,H293423 H294046; ; H294451 ,H294706 ,H290274 ,HCX4344 ,H294044 ,H293364 ,H293559 ,H293604 H294152; ; H294312 ,H294713 ,H290400 ,H140090 ,H140878 ,H293704 ,H293570 ,H293657 H140804; ; H294407 ,H294715 ,H290399 ,H140101 ,H140803 ,H293553 ,H293390 ,H293767 H294071; ; H294260 ,H294726 ,H272359 ,H290517 ,H273112 ,H293631 ,H293599 ,H290372 H140814; ; H294066 ,H294728 ,H290501 ,H140121 ,H273176 ,H293628 ,H293446 ,H294037 H294154; ; H294463 ,H294731 ,H291211 ,H140062 ,H294108 ,H293679 ,H293382 ,H294082 H294195; ; H294503 ,H294732 ,H293596 ,H140143 ,H294190 ,H293794 ,H293383 ,H140790 H294220; ; H294087 ,H294736 ,H293741 ,H293384 ,H294191 ,H293386 ,H140730 ,H294219 H294176; ; H294213 ,H294737 ,H293866 ,H140705 ,H294520 ,H293471 ,H293712 ,H294681 H294165; ; H294580 ,H293603 ,H293964 ,H293328 ,H294606 ,H293629 ,H293497 ,H294682 H294258; ; H294583 ,H294093 ,H294331 ,H140134 ,H290256 ,H293785 ,H293849 ,H271400 H294271; ; H294492 ,H294491 ,H140877 ,H293637 ,H271890 ,H293786 ,H293852 ,H272397 H294270; ; H294582 ,H294279 ,H272418 ,H140745 ,H273173 ,H293870 ,H293951 ,H272427 H294276; ; H294508 ,H294533 ,H291009 ,H140750 ,H273155 ,H294038 ,H293941 ,H290511 H294277; ; H294590 ,H293550 ,H291103 ,H140741 ,H293372 ,H293904 ,H293972 ,H272911 H294278; ; H294632 ,H293938 ,H293531 ,H140749 ,H293977 ,H293905 ,H294193 ,H291033 H294289; ; H294339 ,H294489 ,H140752 ,H294070 ,H294055 ,H293510 ,H294192 ,H290540 H294216; ; H294094 ,H290262 ,H293574 ,H294072 ,H140743 ,H293869 ,H294208 ,H291213 H294217; ; H294637 ,H290263 ,H293996 ,H140805 ,H140771 ,H294047 ,H294211 ,H291232 H294281; ; H294537 ,H290352 ,H294081 ,H294069 ,H294214 ,H294059 ,H294389 ,H293577 H294272; ; H294649 ,H291046 ,H294523 ,H140859 ,H294779 ,H140818 ,H294014 ,H293593 H294306; ; H294619 ,H293630 ,H290423 ,H140861 ,H294565 ,H293878 ,H293990 ,H293492 H294288; ; H294663 ,H140823 ,H291007 ,H291059 ,H273142 ,H294147 ,H293991 ,H293649 H293667; ; H293511 ,H272908 ,H294102 ,H290249 ,H140001 ,H272014 ,H140046 ,H272401 H293742; ; H293339 ,H273004 ,H294076 ,H271393 ,H271760 ,H290362 ,H272238 ,H272394 H293652; ; H290560 ,H273049 ,H294077 ,H271407 ,H271762 ,H272009 ,H272237 ,H272801 H293818; ; H294639 ,H272469 ,H294078 ,H271413 ,H271785 ,H271975 ,H272236 ,H272456 H293834; ; H294640 ,H273063 ,H294079 ,H271385 ,H271780 ,H271964 ,H272259 ,H272470 H293778; ; H291233 ,H273105 ,H294218 ,H271439 ,H271797 ,H272052 ,H290392 ,H272500 H293914; ; H293879 ,H291152 ,H293867 ,H271452 ,H271835 ,H272000 ,H272271 ,H272803 H293928; ; H273149 ,H291151 ,H294257 ,H271438 ,H271838 ,H272043 ,H140058 ,H272454 H293965; ; H273152 ,H140224 ,H294354 ,H271425 ,H271831 ,H272035 ,H272301 ,H272466 H293981; ; H293323 ,H140225 ,H294263 ,H271502 ,H271783 ,H140038 ,H272306 ,H272479 H293993; ; H273114 ,H140226 ,H294323 ,H271515 ,H271858 ,H272045 ,H290397 ,H272491 H140797; ; H293315 ,H140227 ,H294321 ,H271519 ,H271856 ,H271951 ,H272307 ,H140088 H294305; ; H293584 ,H291271 ,H294320 ,H271526 ,H271862 ,H272049 ,H272291 ,H272480 H140864; ; H293739 ,H273206 ,H294322 ,H271507 ,H271833 ,H290376 ,H272321 ,H140092 H273143; ; H293803 ,H293325 ,H294268 ,H271523 ,H140011 ,H271942 ,H272325 ,H140201 H271994; ; H293687 ,H293326 ,H294539 ,H290287 ,H271879 ,H272062 ,H272293 ,H290505 H291008; ; H293795 ,H293207 ,H294541 ,H271497 ,H271825 ,H272069 ,H272326 ,H272816 H291182; ; H293865 ,H293356 ,H294171 ,H271559 ,H271870 ,H272001 ,H272302 ,H290503 H291108; ; H294110 ,H293327 ,H294540 ,H271587 ,H271893 ,H272086 ,H272346 ,H272476 H293311; ; H294111 ,H293416 ,H294538 ,H271588 ,H271896 ,H272078 ,H290405 ,H272811 H293331; ; H294040 ,H293417 ,H294621 ,H271420 ,H271900 ,H272089 ,H272345 ,H290509 H293556; ; H293301 ,H293377 ,H294620 ,H271594 ,H290341 ,H140043 ,H140073 ,H272837 H293507; ; H293314 ,H273055 ,H294716 ,H271607 ,H271903 ,H290371 ,H290402 ,H272822 H293747; ; H294345 ,H293441 ,H140893 ,H271626 ,H140018 ,H272081 ,H140071 ,H272824 H140795; ; H294412 ,H293583 ,H270788 ,H271669 ,H271921 ,H272129 ,H272336 ,H272488 H293740; ; H294411 ,H293674 ,H271041 ,H271664 ,H290326 ,H272134 ,H140067 ,H272854 H293980; ; H294379 ,H293671 ,H270862 ,H290304 ,H271906 ,H140045 ,H272354 ,H272860 H293872; ; H294438 ,H293672 ,H271066 ,H271691 ,H271918 ,H272143 ,H272365 ,H140098 H293875; ; H294439 ,H293670 ,H271105 ,H290313 ,H271895 ,H272172 ,H272341 ,H272841 H293960; ; H294388 ,H293716 ,H271169 ,H290308 ,H271935 ,H272187 ,H272355 ,H272862 H140829; ; H294644 ,H293715 ,H290241 ,H271678 ,H271966 ,H272178 ,H272377 ,H290510 H291272; ; H273056 ,H293717 ,H271167 ,H271618 ,H140026 ,H290379 ,H140076 ,H272873 H293496; ; H293752 ,H293718 ,H271242 ,H140020 ,H140027 ,H272202 ,H272388 ,H290508 H293600; ; H294255 ,H293669 ,H290222 ,H271711 ,H140031 ,H272174 ,H272410 ,H272866 H293638; ; H293751 ,H293804 ,H271362 ,H271693 ,H271993 ,H272209 ,H272422 ,H272868 H293848; ; H273148 ,H293820 ,H271194 ,H271712 ,H271961 ,H272220 ,H272428 ,H272872 H294141; ; H294657 ,H293782 ,H271308 ,H271720 ,H271974 ,H272204 ,H140078 ,H272847 H294265; ; H271954 ,H293826 ,H290224 ,H271729 ,H140025 ,H140047 ,H140077 ,H272885 H294284; ; H271872 ,H293713 ,H271334 ,H271714 ,H272029 ,H272231 ,H272426 ,H272914 H290550; ; H272826 ,H293714 ,H290243 ,H271724 ,H272003 ,H272223 ,H272444 ,H291002 H290600; ; H273029 ,H291076 ,H291048 ,H273135 ,H291219 ,H293303 ,H293318 ,H293432 H272893; ; H291028 ,H291077 ,H291088 ,H291140 ,H140233 ,H291236 ,H293357 ,H293425 H290520; ; H273030 ,H291052 ,H140211 ,H291045 ,H291202 ,H293332 ,H291229 ,H293300 H291006; ; H291032 ,H291079 ,H291099 ,H291109 ,H291169 ,H291266 ,H291249 ,H293438 H140109; ; H272971 ,H272978 ,H140215 ,H291117 ,H291200 ,H291247 ,H140149 ,H140706 H272899; ; H291027 ,H291073 ,H140133 ,H291111 ,H291218 ,H291256 ,H293313 ,H293366 H291001; ; H291025 ,H291067 ,H291120 ,H291116 ,H291170 ,H291270 ,H291252 ,H293404 H291004; ; H291026 ,H291078 ,H291136 ,H291157 ,H291196 ,H291253 ,H140703 ,H293348 H272926; ; H291038 ,H291063 ,H140219 ,H291161 ,H291221 ,H293316 ,H293345 ,H293486 H272938; ; H273016 ,H140216 ,H273120 ,H291113 ,H291222 ,H140240 ,H293429 ,H293397 H290519; ; H272982 ,H140213 ,H273109 ,H140220 ,H291207 ,H293308 ,H293431 ,H293490 H291003; ; H291023 ,H291090 ,H291149 ,H291092 ,H291209 ,H293322 ,H293385 ,H293503 H140111; ; H272990 ,H291068 ,H291134 ,H273137 ,H140228 ,H291224 ,H293426 ,H291176 H140202; ; H291029 ,H291074 ,H291096 ,H273136 ,H291133 ,H291243 ,H293342 ,H293439 H272960; ; H291020 ,H140217 ,H291139 ,H291162 ,H291181 ,H291225 ,H293360 ,H293508 H272981; ; H291042 ,H273026 ,H273118 ,H291183 ,H291171 ,H291267 ,H293418 ,H293485 H272842; ; H272825 ,H291072 ,H291142 ,H291150 ,H291185 ,H291245 ,H293428 ,H293518 H291013; ; H291035 ,H291080 ,H291094 ,H291131 ,H291216 ,H291258 ,H293414 ,H293406 H291005; ; H291039 ,H291097 ,H140218 ,H291053 ,H291203 ,H291255 ,H291226 ,H293354 H140205; ; H291043 ,H291093 ,H140221 ,H140223 ,H291210 ,H290558 ,H291248 ,H293459 H291010; ; H272987 ,H291100 ,H291101 ,H273158 ,H273199 ,H293343 ,H291263 ,H293476 H272846; ; H140207 ,H291105 ,H291146 ,H291159 ,H291208 ,H293358 ,H293436 ,H140720 H272848; ; H291041 ,H291066 ,H140222 ,H291135 ,H291234 ,H293329 ,H293403 ,H293466 H290504; ; H291049 ,H291069 ,H140209 ,H291186 ,H291235 ,H293340 ,H293460 ,H293483 H290512; ; H273052 ,H291081 ,H291119 ,H291192 ,H291215 ,H293335 ,H293413 ,H293405 H272956; ; H273040 ,H291061 ,H291123 ,H291184 ,H291220 ,H293350 ,H140239 ,H293488 H272963; ; H291050 ,H273075 ,H291129 ,H291187 ,H291206 ,H293309 ,H293402 ,H293420 H272993; ; H291056 ,H140214 ,H291121 ,H291144 ,H291241 ,H293346 ,H293472 ,H293433 H272999; ; H291065 ,H140206 ,H291122 ,H291143 ,H140237 ,H291230 ,H293398 ,H293484 H291024; ; H140212 ,H291106 ,H291112 ,H291167 ,H291175 ,H293352 ,H140714 ,H140722 H291012; ; H291057 ,H291102 ,H291145 ,H291158 ,H291217 ,H293302 ,H293453 ,H293401 H272986; ; H291058 ,H291084 ,H273141 ,H291177 ,H291264 ,H291240 ,H293445 ,H293541 H291019; ; H291070 ,H291086 ,H291153 ,H273157 ,H273190 ,H293361 ,H293437 ,H293548 H140115; ; H291071 ,H291087 ,H291118 ,H291148 ,H273209 ,H291269 ,H293427 ,H293344 H291017; ; H273053 ,H291089 ,H291155 ,H291188 ,H291242 ,H291251 ,H293457 ,H293480 H291014; ; H291047 ,H291107 ,H291125 ,H291197 ,H291173 ,H293317 ,H140716 ,H293481 H291030; ; H291051 ,H272996 ,H291126 ,H140230 ,H291246 ,H293330 ,H293461 ,H293478 H291034; ; H291062 ,H291104 ,H291138 ,H291189 ,H291214 ,H291239 ,H293462 ,H293536 H290530; ; H291031 ,H291040 ,H291147 ,H291193 ,H291273 ,H291265 ,H293355 ,H293581 H291036; ; H291060 ,H140210 ,H291156 ,H291124 ,H291228 ,H293399 ,H293415 ,H293319 H293501; ; H293591 ,H293673 ,H293695 ,H293873 ,H293919 ,H294032 ,H140806 ,H294184 H293517; ; H293562 ,H293690 ,H140733 ,H293891 ,H140791 ,H294045 ,H294105 ,H294166 H293519; ; H293504 ,H293587 ,H293771 ,H293890 ,H293926 ,H294030 ,H294112 ,H294178 H293473; ; H293590 ,H293689 ,H293756 ,H293880 ,H293932 ,H294006 ,H294053 ,H294209 H293458; ; H293592 ,H293706 ,H140736 ,H293855 ,H293925 ,H294033 ,H293986 ,H140813 H293367; ; H293538 ,H293647 ,H293611 ,H293868 ,H293948 ,H294041 ,H294125 ,H294194 H293568; ; H293608 ,H293700 ,H293783 ,H140780 ,H293956 ,H294051 ,H140807 ,H294234 H293564; ; H293539 ,H293696 ,H293790 ,H293877 ,H293930 ,H294026 ,H140808 ,H294227 H293579; ; H140701 ,H293694 ,H293750 ,H293885 ,H140793 ,H294048 ,H140810 ,H294207 H293475; ; H293610 ,H293554 ,H293806 ,H293864 ,H293962 ,H294039 ,H294130 ,H294116 H291095; ; H140746 ,H293702 ,H140765 ,H293882 ,H293966 ,H293974 ,H294095 ,H294101 H293359; ; H140718 ,H293692 ,H293708 ,H140784 ,H293899 ,H293994 ,H294106 ,H294197 H293544; ; H140735 ,H293693 ,H293658 ,H293701 ,H293967 ,H294004 ,H294122 ,H294181 H293552; ; H293522 ,H293699 ,H293769 ,H293862 ,H293936 ,H294031 ,H294142 ,H294196 H293565; ; H293543 ,H293703 ,H293821 ,H293913 ,H293953 ,H294008 ,H294132 ,H294188 H293589; ; H293594 ,H293746 ,H293819 ,H140770 ,H293971 ,H294063 ,H294157 ,H294237 H293347; ; H293505 ,H291201 ,H293824 ,H293888 ,H293957 ,H294003 ,H294151 ,H294131 H293487; ; H293642 ,H293733 ,H140776 ,H293902 ,H293934 ,H293984 ,H294099 ,H294202 H293514; ; H293648 ,H140757 ,H293789 ,H293900 ,H293950 ,H294024 ,H294054 ,H294225 H293516; ; H293588 ,H293709 ,H293825 ,H140783 ,H293969 ,H294028 ,H294135 ,H294029 H293467; ; H293606 ,H293734 ,H293754 ,H293886 ,H293995 ,H294025 ,H140809 ,H294148 H293513; ; H293537 ,H293685 ,H293802 ,H293910 ,H293975 ,H294061 ,H294137 ,H294162 H293515; ; H293520 ,H293535 ,H293573 ,H293912 ,H293987 ,H294052 ,H140811 ,H294163 H293546; ; H293551 ,H293659 ,H293805 ,H293889 ,H140782 ,H294050 ,H294156 ,H294240 H293614; ; H293621 ,H293707 ,H293836 ,H293874 ,H293952 ,H294056 ,H294159 ,H294243 H140725; ; H293622 ,H293743 ,H293822 ,H293893 ,H293988 ,H293983 ,H294168 ,H140821 H293525; ; H293660 ,H293723 ,H293846 ,H293903 ,H293985 ,H294086 ,H294058 ,H294244 H293617; ; H293639 ,H291244 ,H140778 ,H293915 ,H293921 ,H140799 ,H294179 ,H294252 H140721; ; H140738 ,H293744 ,H140777 ,H293935 ,H294009 ,H294088 ,H140801 ,H294149 H140726; ; H293636 ,H293748 ,H293856 ,H140787 ,H293979 ,H294075 ,H294169 ,H294126 H140727; ; H293607 ,H140753 ,H293831 ,H293772 ,H294010 ,H294064 ,H294172 ,H294127 H273196; ; H293571 ,H140761 ,H293851 ,H293931 ,H294021 ,H294000 ,H294155 ,H294128 H293615; ; H293683 ,H293737 ,H293840 ,H293894 ,H293989 ,H294089 ,H294177 ,H294245 H140723; ; H293563 ,H293341 ,H293859 ,H293923 ,H293976 ,H294091 ,H294187 ,H294254 H293609; ; H140710 ,H140737 ,H293835 ,H293901 ,H294016 ,H294120 ,H140800 ,H294269 H293560; ; H293684 ,H293749 ,H293863 ,H293892 ,H294012 ,H140802 ,H140817 ,H140820 H293470; ; H293493 ,H293688 ,H293664 ,H140781 ,H294018 ,H294007 ,H294182 ,H294267 H293635; ; H293613 ,H293780 ,H293858 ,H293916 ,H294013 ,H294083 ,H294170 ,H294226 H293627; ; H293691 ,H293775 ,H293837 ,H293933 ,H294001 ,H294035 ,H294189 ,H294266 H140744; ; H293605 ,H293777 ,H293871 ,H140792 ,H294020 ,H294090 ,H294180 ,H294285 H294261; ; H294360 ,H294397 ,H294521 ,H294572 ,H140883 ,H294282 ,H294394 ,H293833 H140825; ; H294158 ,H294421 ,H294443 ,H294577 ,H294698 ,H294294 ,H294365 ,H294486 H294275; ; H294326 ,H294427 ,H294509 ,H294458 ,H294660 ,H294328 ,H294393 ,H294475 H294150; ; H294366 ,H294425 ,H294406 ,H294507 ,H294679 ,H294324 ,H294381 ,H294430 H294235; ; H294358 ,H294429 ,H294530 ,H294571 ,H294696 ,H294325 ,H294380 ,H294479 H140824; ; H140838 ,H140848 ,H294534 ,H294574 ,H294711 ,H140831 ,H294395 ,H294494 H140827; ; H294246 ,H294436 ,H294517 ,H294236 ,H294720 ,H294336 ,H294399 ,H294418 H294287; ; H294333 ,H294437 ,H294470 ,H294598 ,H294719 ,H140832 ,H294362 ,H294478 H294286; ; H294355 ,H294424 ,H294510 ,H140855 ,H294712 ,H294332 ,H294372 ,H294482 H294295; ; H294361 ,H294426 ,H294513 ,H294603 ,H294677 ,H294348 ,H294398 ,H294504 H294224; ; H294373 ,H294469 ,H294516 ,H294604 ,H294686 ,H294350 ,H294420 ,H294485 H294299; ; H294340 ,H140851 ,H294524 ,H294616 ,H140897 ,H294353 ,H294408 ,H294481 H294298; ; H294392 ,H294444 ,H294441 ,H140816 ,H294738 ,H294341 ,H294385 ,H294499 H294301; ; H294376 ,H294468 ,H294544 ,H294599 ,H294735 ,H140833 ,H140846 ,H294483 H294316; ; H294174 ,H140852 ,H294528 ,H294595 ,H294729 ,H294337 ,H294413 ,H294514 H294302; ; H294377 ,H294359 ,H294518 ,H294612 ,H294742 ,H294343 ,H294442 ,H140854 H140812; ; H140830 ,H294472 ,H294206 ,H294629 ,H294727 ,H294330 ,H294404 ,H294484 H294303; ; H294378 ,H140826 ,H294546 ,H294625 ,H140891 ,H140835 ,H294410 ,H294505 H294314; ; H294384 ,H294416 ,H140845 ,H140867 ,H294743 ,H140837 ,H294417 ,H294501 H294476; ; H294615 ,H140881 ,H294493 ,H140868 ,H294747 ,H294221 ,H294386 ,H140853 H294554; ; H294576 ,H140895 ,H294531 ,H294555 ,H294753 ,H294327 ,H294382 ,H294497 H294556; ; H294630 ,H140896 ,H294487 ,H140869 ,H294689 ,H294498 ,H294617 ,H294690 H294552; ; H294613 ,H294730 ,H294300 ,H294624 ,H294761 ,H294500 ,H294642 ,H294763 H294506; ; H294653 ,H294771 ,H294431 ,H294652 ,H294783 ,H294391 ,H294567 ,H140702 H294549; ; H294658 ,H294773 ,H294311 ,H294654 ,H294794 ,H294573 ,H294694 ,H294253 H294575; ; H294680 ,H294782 ,H294446 ,H294665 ,H291091 ,H140858 ,H294626 ,HCX4019 H294550; ; H294695 ,H294291 ,H140876 ,H293542
• Recalling Firm/ Manufacturer: Varian Medical Systems Oncology Systems; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: 650-424-5731
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• 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.
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GKZ and Original Applicant = VARIAN ASSOC., INC.; 510(K)s with Product Code = GKZ and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.