• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Varis, Aria Radiation Oncology Version 8.1.15, 8.5.11, and 8.6.07

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Varis, Aria Radiation Oncology Version 8.1.15, 8.5.11, and 8.6.07 see related information
Date Initiated by Firm May 08, 2009
Date Posted August 27, 2009
Recall Status1 Terminated 3 on December 23, 2011
Recall Number Z-1809-2009
Recall Event ID 52654
510(K)Number K001643  
Product Classification Linear Medical Accelerator - Product Code IYE
Product Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, Manufactured by Varian Medical Systems Inc., Palo Alto, CA

The Varis RV function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan. Additional applications provide various data management and library functions.
Code Information Code numbers H140001 H140136 H140221 H140719 H140759 H140798 H271041 H271626 H271951 H272197 H140011 H140137 H140222 H140720 H140760 H140799 H271066 H271662 H271961 H272202 H140018 H140138 H140223 H140721 H140761 H140800 H271157 H271664 H271964 H272209 H140020 H140139 H140224 H140722 H140762 H140801 H271159 H271681 H271966 H272219 H140025 H140140 H140225 H140723 H140763 H140802 H271167 H271693 H271973 H272220 H140026 H140141 H140226 H140724 H140764 H140804 H271169 H271711 H271974 H272223 H140027 H140142 H140227 H140725 H140765 H140805 H271190 H271720 H271975 H272231 H140031 H140143 H140228 H140726 H140766 H140806 H271194 H271724 H271976 H272236 H140043 H140144 H140229 H140727 H140767 H140807 H271242 H271762 H271993 H272237 H140045 H140145 H140230 H140728 H140768 H140808 H271258 H271780 H271994 H272238 H140046 H140146 H140231 H140729 H140769 H140809 H271265 H271783 H272000 H272259 H140047 H140147 H140232 H140730 H140770 H140810 H271308 H271785 H272009 H272271 H140058 H140148 H140233 H140731 H140771 H140811 H271334 H271797 H272023 H272277 H140062 H140149 H140234 H140732 H140772 H140812 H271362 H271802 H272029 H272283 H140067 H140150 H140235 H140733 H140773 H140813 H271370 H271825 H272033 H272291 H140070 H140151 H140236 H140734 H140774 H140814 H271385 H271831 H272035 H272299 H140071 H140152 H140237 H140735 H140775 H140815 H271393 H271833 H272043 H272301 H140073 H140153 H140238 H140736 H140776 H140817 H271400 H271835 H272045 H272302 H140076 H140154 H140239 H140737 H140777 H140819 H271407 H271838 H272049 H272306 H140077 H140201 H140240 H140739 H140778 H140820 H271413 H271856 H272052 H272307 H140088 H140202 H140700 H140740 H140779 H140821 H271425 H271858 H272062 H272309 H140090 H140203 H140701 H140741 H140780 H140822 H271438 H271860 H272069 H272310 H140092 H140204 H140702 H140742 H140781 H140824 H271439 H271862 H272078 H272311 H140096 H140205 H140703 H140743 H140782 H140825 H271452 H271870 H272086 H272325 H140097 H140206 H140704 H140744 H140783 H140826 H271497 H271872 H272089 H272326 H140098 H140207 H140705 H140745 H140784 H140827 H271502 H271879 H272111 H272327 H140101 H140208 H140706 H140746 H140785 H140828 H271507 H271881 H272129 H272328 H140109 H140209 H140707 H140747 H140786 H140830 H271515 H271893 H272134 H272329 H140111 H140210 H140708 H140748 H140787 H140831 H271519 H271895 H272137 H272333 H140114 H140211 H140709 H140749 H140788 H140832 H271523 H271896 H272143 H272345 H140115 H140212 H140710 H140750 H140789 H140833 H271531 H271900 H272157 H272346 H140117 H140213 H140711 H140751 H140790 H140834 H271559 H271903 H272159 H272354 H140119 H140214 H140712 H140752 H140791 H140835 H271582 H271906 H272162 H272355 H140121 H140215 H140713 H140753 H140792 H140836 H271587 H271918 H272172 H272359 H140124 H140216 H140714 H140754 H140793 H140837 H271588 H271921 H272174 H272362 H140125 H140217 H140715 H140755 H140794 H140838 H271593 H271926 H272178 H272365 H140133 H140218 H140716 H140756 H140795 H270788 H271594 H271935 H272187 H272370 H140134 H140219 H140717 H140757 H140796 H270794 H271607 H271941 H272188 H272372 H140135 H140220 H140718 H140758 H140797 H270862 H271624 H271942 H272195 H272388 H272394 H272859 H273049 H273132 H273179 H290278 H290557 H291040 H291085 H291131 H272397 H272860 H273053 H273133 H273180 H290282 H290558 H291041 H291086 H291132 H272401 H272862 H273055 H273134 H273181 H290287 H290559 H291042 H291087 H291133 H272405 H272866 H273056 H273135 H273182 H290304 H290560 H291043 H291088 H291134 H272407 H272868 H273063 H273136 H273183 H290308 H290561 H291044 H291089 H291135 H272410 H272872 H273064 H273137 H273184 H290313 H290600 H291045 H291090 H291136 H272418 H272873 H273065 H273138 H273185 H290326 H291001 H291046 H291091 H291137 H272421 H272875 H273066 H273139 H273186 H290341 H291002 H291047 H291092 H291138 H272422 H272885 H273072 H273140 H273187 H290352 H291003 H291048 H291093 H291139 H272425 H272889 H273077 H273141 H273188 H290371 H291004 H291049 H291094 H291140 H272426 H272893 H273080 H273142 H273189 H290372 H291005 H291050 H291095 H291141 H272427 H272905 H273082 H273143 H273190 H290376 H291006 H291051 H291096 H291142 H272428 H272908 H273083 H273144 H273191 H290379 H291007 H291052 H291097 H291143 H272434 H272909 H273084 H273145 H273192 H290386 H291008 H291053 H291098 H291144 H272454 H272922 H273092 H273146 H273193 H290392 H291009 H291054 H291099 H291145 H272456 H272926 H273101 H273147 H273194 H290397 H291010 H291055 H291100 H291146 H272458 H272932 H273102 H273148 H273195 H290399 H291011 H291056 H291101 H291147 H272466 H272938 H273103 H273149 H273196 H290400 H291012 H291057 H291102 H291148 H272469 H272946 H273104 H273150 H273197 H290405 H291013 H291058 H291103 H291149 H272470 H272956 H273105 H273151 H273198 H290423 H291014 H291059 H291104 H291150 H272473 H272960 H273106 H273152 H273199 H290503 H291015 H291060 H291105 H291151 H272479 H272964 H273107 H273153 H273200 H290504 H291016 H291061 H291106 H291152 H272480 H272971 H273108 H273155 H273201 H290505 H291017 H291062 H291107 H291153 H272488 H272973 H273109 H273156 H273202 H290508 H291018 H291063 H291108 H291154 H272492 H272978 H273110 H273157 H273203 H290509 H291019 H291064 H291109 H291155 H272494 H272981 H273111 H273158 H273204 H290510 H291020 H291065 H291111 H291156 H272497 H272982 H273112 H273159 H273205 H290511 H291021 H291066 H291112 H291157 H272500 H272985 H273113 H273160 H273206 H290512 H291022 H291067 H291113 H291158 H272801 H272986 H273114 H273162 H273208 H290517 H291023 H291068 H291114 H291159 H272803 H272987 H273115 H273163 H273209 H290519 H291024 H291069 H291115 H291160 H272811 H272990 H273116 H273164 H273210 H290520 H291025 H291070 H291116 H291161 H272816 H272996 H273117 H273165 H273528 H290530 H291026 H291071 H291117 H291162 H272822 H272999 H273118 H273166 H273547 H290533 H291027 H291072 H291118 H291163 H272824 H273004 H273119 H273167 H273578 H290540 H291028 H291073 H291119 H291164 H272825 H273011 H273120 H273168 H273711 H290541 H291029 H291074 H291120 H291165 H272826 H273016 H273121 H273169 H273929 H290547 H291030 H291075 H291121 H291166 H272828 H273026 H273122 H273170 H290201 H290548 H291031 H291076 H291122 H291167 H272834 H273027 H273123 H273171 H290222 H290549 H291032 H291077 H291123 H291168 H272837 H273030 H273124 H273172 H290224 H290550 H291033 H291078 H291124 H291169 H272841 H273031 H273125 H273173 H290241 H290551 H291034 H291079 H291125 H291170 H272842 H273036 H273126 H273174 H290243 H290552 H291035 H291080 H291126 H291171 H272846 H273039 H273127 H273175 H290249 H290553 H291036 H291081 H291127 H291172 H272848 H273040 H273128 H273176 H290262 H290554 H291037 H291082 H291128 H291173 H272854 H273042 H273130 H273177 H290263 H290555 H291038 H291083 H291129 H291174 H272857 H273048 H273131 H273178 H290274 H290556 H291039 H291084 H291130 H291175 H291176 H291221 H291266 H293333 H293379 H293425 H293470 H293515 H293563 H293610 H291177 H291222 H291267 H293334 H293380 H293426 H293471 H293516 H293564 H293611 H291178 H291223 H291268 H293335 H293381 H293427 H293472 H293517 H293565 H293612 H291179 H291224 H291269 H293336 H293382 H293428 H293473 H293518 H293566 H293613 H291180 H291225 H291270 H293337 H293383 H293429 H293474 H293519 H293567 H293614 H291181 H291226 H291271 H293339 H293384 H293430 H293475 H293520 H293568 H293615 H291182 H291227 H291272 H293340 H293385 H293431 H293476 H293521 H293569 H293616 H291183 H291228 H291273 H293341 H293386 H293432 H293477 H293522 H293570 H293617 H291184 H291229 H292366 H293342 H293387 H293433 H293478 H293523 H293571 H293618 H291185 H291230 H292832 H293343 H293388 H293434 H293479 H293524 H293572 H293619 H291186 H291231 H293009 H293344 H293389 H293435 H293480 H293525 H293573 H293620 H291187 H291232 H293207 H293345 H293390 H293436 H293481 H293527 H293574 H293621 H291188 H291233 H293300 H293346 H293391 H293437 H293482 H293529 H293575 H293622 H291189 H291234 H293301 H293347 H293392 H293438 H293483 H293530 H293576 H293623 H291190 H291235 H293302 H293348 H293393 H293439 H293484 H293531 H293577 H293624 H291191 H291236 H293303 H293349 H293394 H293440 H293485 H293532 H293578 H293625 H291192 H291237 H293304 H293350 H293395 H293441 H293486 H293533 H293579 H293626 H291193 H291238 H293305 H293351 H293396 H293442 H293487 H293534 H293581 H293627 H291194 H291239 H293306 H293352 H293397 H293443 H293488 H293535 H293583 H293628 H291195 H291240 H293307 H293353 H293398 H293444 H293489 H293536 H293584 H293629 H291196 H291241 H293308 H293354 H293399 H293445 H293490 H293537 H293585 H293630 H291197 H291242 H293309 H293355 H293401 H293446 H293491 H293538 H293586 H293631 H291198 H291243 H293310 H293356 H293402 H293447 H293492 H293539 H293587 H293632 H291199 H291244 H293311 H293357 H293403 H293448 H293493 H293540 H293588 H293633 H291200 H291245 H293312 H293358 H293404 H293449 H293494 H293541 H293589 H293634 H291201 H291246 H293313 H293359 H293405 H293450 H293495 H293542 H293590 H293635 H291202 H291247 H293314 H293360 H293406 H293451 H293496 H293543 H293591 H293636 H291203 H291248 H293315 H293361 H293407 H293452 H293497 H293544 H293592 H293637 H291204 H291249 H293316 H293362 H293408 H293453 H293498 H293545 H293593 H293638 H291205 H291250 H293317 H293363 H293409 H293454 H293499 H293546 H293594 H293639 H291206 H291251 H293318 H293364 H293410 H293455 H293500 H293548 H293595 H293640 H291207 H291252 H293319 H293365 H293411 H293456 H293501 H293549 H293596 H293641 H291208 H291253 H293320 H293366 H293412 H293457 H293502 H293550 H293597 H293642 H291209 H291254 H293321 H293367 H293413 H293458 H293503 H293551 H293598 H293643 H291210 H291255 H293322 H293368 H293414 H293459 H293504 H293552 H293599 H293644 H291211 H291256 H293323 H293369 H293415 H293460 H293505 H293553 H293600 H293645 H291212 H291257 H293324 H293370 H293416 H293461 H293506 H293554 H293601 H293646 H291213 H291258 H293325 H293371 H293417 H293462 H293507 H293555 H293602 H293647 H291214 H291259 H293326 H293372 H293418 H293463 H293508 H293556 H293603 H293648 H291215 H291260 H293327 H293373 H293419 H293464 H293509 H293557 H293604 H293649 H291216 H291261 H293328 H293374 H293420 H293465 H293510 H293558 H293605 H293650 H291217 H291262 H293329 H293375 H293421 H293466 H293511 H293559 H293606 H293651 H291218 H291263 H293330 H293376 H293422 H293467 H293512 H293560 H293607 H293652 H291219 H291264 H293331 H293377 H293423 H293468 H293513 H293561 H293608 H293653 H291220 H291265 H293332 H293378 H293424 H293469 H293514 H293562 H293609 H293654 H293655 H293702 H293750 H293798 H293846 H293891 H293941 H293989 H294037 H294085 H293656 H293703 H293751 H293799 H293847 H293892 H293942 H293990 H294038 H294086 H293657 H293704 H293752 H293800 H293848 H293893 H293943 H293991 H294039 H294088 H293658 H293705 H293753 H293801 H293849 H293894 H293944 H293992 H294040 H294089 H293659 H293706 H293754 H293802 H293850 H293895 H293946 H293993 H294041 H294090 H293660 H293707 H293755 H293803 H293851 H293896 H293947 H293994 H294042 H294091 H293661 H293708 H293756 H293804 H293852 H293897 H293948 H293995 H294043 H294092 H293662 H293709 H293758 H293805 H293853 H293898 H293949 H293996 H294044 H294093 H293663 H293710 H293759 H293806 H293854 H293899 H293950 H293997 H294045 H294095 H293664 H293712 H293760 H293807 H293855 H293900 H293951 H293998 H294046 H294097 H293665 H293713 H293761 H293808 H293856 H293901 H293952 H293999 H294047 H294098 H293666 H293714 H293762 H293809 H293857 H293902 H293953 H294000 H294048 H294099 H293667 H293715 H293763 H293812 H293858 H293903 H293954 H294001 H294049 H294100 H293668 H293716 H293764 H293813 H293859 H293904 H293955 H294002 H294050 H294101 H293669 H293717 H293765 H293814 H293860 H293905 H293956 H294003 H294051 H294102 H293670 H293718 H293767 H293815 H293861 H293907 H293957 H294004 H294052 H294103 H293671 H293719 H293769 H293816 H293862 H293908 H293958 H294005 H294053 H294104 H293672 H293720 H293770 H293817 H293863 H293909 H293959 H294006 H294054 H294105 H293673 H293721 H293771 H293818 H293864 H293910 H293960 H294007 H294055 H294106 H293674 H293723 H293772 H293819 H293865 H293911 H293962 H294008 H294056 H294107 H293675 H293724 H293773 H293820 H293866 H293912 H293963 H294009 H294058 H294108 H293676 H293725 H293774 H293821 H293867 H293913 H293964 H294010 H294059 H294109 H293678 H293726 H293775 H293822 H293868 H293914 H293965 H294011 H294060 H294110 H293679 H293727 H293776 H293823 H293869 H293915 H293966 H294012 H294061 H294111 H293681 H293728 H293777 H293824 H293870 H293916 H293967 H294013 H294062 H294112 H293682 H293729 H293778 H293825 H293871 H293917 H293968 H294016 H294063 H294113 H293683 H293730 H293779 H293826 H293872 H293918 H293969 H294017 H294064 H294114 H293684 H293732 H293780 H293827 H293873 H293919 H293970 H294018 H294065 H294116 H293685 H293733 H293781 H293828 H293874 H293920 H293971 H294020 H294067 H294117 H293686 H293734 H293782 H293829 H293875 H293921 H293972 H294021 H294068 H294118 H293687 H293735 H293783 H293830 H293876 H293922 H293974 H294022 H294069 H294119 H293688 H293736 H293784 H293831 H293877 H293923 H293975 H294023 H294070 H294120 H293689 H293737 H293785 H293832 H293878 H293924 H293976 H294024 H294071 H294121 H293690 H293738 H293786 H293834 H293879 H293925 H293977 H294025 H294072 H294122 H293691 H293739 H293787 H293835 H293880 H293926 H293978 H294026 H294073 H294123 H293692 H293740 H293788 H293836 H293881 H293928 H293979 H294027 H294074 H294124 H293693 H293741 H293789 H293837 H293882 H293929 H293980 H294028 H294075 H294125 H293694 H293742 H293790 H293838 H293883 H293930 H293981 H294029 H294076 H294126 H293695 H293743 H293791 H293839 H293884 H293931 H293982 H294030 H294077 H294127 H293696 H293744 H293792 H293840 H293885 H293932 H293983 H294031 H294078 H294128 H293697 H293745 H293793 H293841 H293886 H293933 H293984 H294032 H294079 H294129 H293698 H293746 H293794 H293842 H293887 H293934 H293985 H294033 H294080 H294130 H293699 H293747 H293795 H293843 H293888 H293935 H293986 H294034 H294081 H294131 H293700 H293748 H293796 H293844 H293889 H293936 H293987 H294035 H294082 H294132 H293701 H293749 H293797 H293845 H293890 H293938 H293988 H294036 H294083 H294133 H294134 H294186 H294240 H294299 H294366 H294168 H294217 H294273 H294327 H294298 H294135 H294187 H294241 H294301 H294372 H294169 H294218 H294275 H294328 H294361 H294136 H294188 H294242 H294302 H294373 H294170 H294219 H294276 H294330 H294363 H294137 H294189 H294243 H294303 H294376 H294172 H294220 H294277 H294331 H294364 H294138 H294190 H294244 H294304 H294377 H294173 H294221 H294278 H294332 H294140 H294191 H294245 H294306 H294378 H294174 H294222 H294279 H294333 H294142 H294192 H294246 H294307 H294380 H294175 H294223 H294280 H294334 H294143 H294193 H294247 H294308 H294381 H294176 H294224 H294281 H294336 H294144 H294194 H294252 H294309 H294382 H294177 H294225 H294282 H294337 H294145 H294195 H294254 H294312 H294384 H294178 H294226 H294283 H294338 H294146 H294196 H294256 H294314 H294386 H294179 H294227 H294285 H294340 H294148 H294197 H294257 H294316 H294389 H294180 H294228 H294286 H294341 H294149 H294198 H294258 H294317 H294392 H294181 H294230 H294287 H294342 H294150 H294199 H294261 H294318 H294159 H294182 H294232 H294288 H294343 H294151 H294200 H294262 H294320 H294161 H294184 H294234 H294289 H294348 H294152 H294201 H294263 H294321 H294162 H294185 H294235 H294290 H294350 H294154 H294202 H294264 H294322 H294163 H294208 H294236 H294293 H294353 H294155 H294203 H294266 H294323 H294164 H294209 H294237 H294294 H294354 H294156 H294204 H294267 H294324 H294165 H294210 H294239 H294295 H294355 H294157 H294205 H294269 H294325 H294166 H294214 H294271 H294296 H294358 H294158 H294207 H294270 H294326 H294167 H294216 H294272 H294297, & H294360.
Recalling Firm/
Varian Medical Systems Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact
Manufacturer Reason
for Recall
Potential mistreatment-- due to software issues, retired plans may be used and treated repeatedly.
FDA Determined
Cause 2
Software design
Action An Urgent Medical Device Correction Letter/ Field Safety Letter, dated May 8, 2009, were distributed to all affected users, with a description of the problem and user corrective action steps. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. The firm intends to produce a software fix for the problem. If further clarification is needed, users should contact their Varian Customer Support District or Regional Manager.
Quantity in Commerce 1,587 units
Distribution Worldwide Distribution
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 = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.