Events

Retiro De Equipo (Recall) de Device Recall Varian High Energy Linear Accelerator

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Varian Medical Systems, Inc. Oncology Systems.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    57610
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1045-2011
  • Fecha de inicio del evento
    2010-12-10
  • Fecha de publicación del evento
    2011-02-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96782
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Linear Accelerator - Product Code IYE
  • Causa
    An anomaly was identified whereby the bolts used to fasten the counterweight to the gantry may not, in some cases, be fully tightened to the required torque specification.
  • Acción
    An Urgent Medical Device Correction letter was sent to all affected users with a description of the problem and user corrective action steps. Letters were sent on 12/10/2010. Users are to immediately investigate any unusual noises coming from the affected product and report them to whoever is responsible for servicing the device. For customers that do have a service contract with Varian, Varian service will perform an inspection of the counterweight bolts as part of the regular Periodic Maintenance Inspection procedure. Customers are to advice the appropriate personnel of the contents of the letter. For further clarification, customers can contact their local Varian Customer Support Services Manager.

Device

Device Recall Varian High Energy Linear Accelerator
  • Modelo / Serial
    Model numbers: H14, H27, H29 and HCX; Serial numbers:  H140002 H140101 H140738 H140901 H270237 H270364 H270462 H270605 H270703 H270793 H270896 H140003 H140103 H140741 H140902 H270240 H270365 H270463 H270606 H270708 H270795 H270897 H140006 H140110 H140743 H140905 H270242 H270370 H270466 H270615 H270709 H270799 H270899 H140009 H140115 H140744 H270001 H270245 H270371 H270470 H270616 H270710 H270800 H271002 H140010 H140117 H140745 H270006 H270251 H270373 H270474 H270617 H270711 H270804 H271004 H140011 H140118 H140746 H270009 H270252 H270377 H270475 H270624 H270712 H270805 H271005 H140012 H140120 H140749 H270010 H270254 H270378 H270476 H270625 H270713 H270809 H271008 H140014 H140121 H140750 H270021 H270256 H270380 H270477 H270626 H270714 H270810 H271009 H140015 H140122 H140751 H270027 H270261 H270385 H270479 H270627 H270715 H270812 H271013 H140017 H140123 H140754 H270029 H270267 H270392 H270482 H270631 H270717 H270820 H271015 H140022 H140124 H140755 H270030 H270270 H270395 H270483 H270633 H270718 H270821 H271017 H140023 H140128 H140756 H270031 H270271 H270396 H270484 H270635 H270721 H270822 H271018 H140024 H140131 H140758 H270038 H270273 H270397 H270486 H270637 H270722 H270825 H271020 H140030 H140132 H140763 H270047 H270274 H270404 H270487 H270639 H270725 H270828 H271021 H140033 H140134 H140770 H270074 H270280 H270408 H270489 H270641 H270727 H270829 H271023 H140034 H140135 H140771 H270075 H270282 H270409 H270495 H270642 H270728 H270832 H271024 H140035 H140136 H140772 H270088 H270284 H270410 H270496 H270643 H270729 H270835 H271025 H140036 H140143 H140778 H270096 H270297 H270412 H270498 H270645 H270730 H270841 H271031 H140039 H140152 H140782 H270101 H270299 H270418 H270499 H270647 H270732 H270847 H271032 H140040 H140203 H140784 H270106 H270300 H270419 H270500 H270648 H270735 H270850 H271033 H140041 H140204 H140795 H270107 H270303 H270420 H270502 H270652 H270736 H270852 H271035 H140042 H140208 H140797 H270109 H270305 H270421 H270503 H270653 H270737 H270854 H271036 H140043 H140211 H140801 H270111 H270307 H270425 H270504 H270654 H270739 H270857 H271039 H140048 H140213 H140802 H270118 H270311 H270426 H270506 H270660 H270740 H270858 H271040 H140052 H140214 H140804 H270126 H270314 H270427 H270510 H270662 H270743 H270859 H271041 H140053 H140215 H140805 H270128 H270321 H270431 H270511 H270663 H270744 H270862 H271047 H140057 H140223 H140818 H270134 H270328 H270433 H270512 H270664 H270749 H270865 H271055 H140058 H140229 H140819 H270136 H270329 H270435 H270514 H270667 H270751 H270867 H271056 H140059 H140231 H140820 H270138 H270335 H270436 H270518 H270671 H270752 H270868 H271061 H140060 H140232 H140823 H270141 H270338 H270437 H270520 H270674 H270757 H270870 H271062 H140061 H140235 H140824 H270143 H270341 H270443 H270522 H270680 H270760 H270872 H271063 H140062 H140236 H140825 H270144 H270343 H270445 H270525 H270681 H270767 H270873 H271071 H140063 H140240 H140829 H270201 H270344 H270446 H270529 H270682 H270769 H270878 H271075 H140065 H140702 H140836 H270209 H270346 H270447 H270530 H270684 H270770 H270880 H271076 H140068 H140705 H140837 H270214 H270349 H270448 H270532 H270685 H270778 H270881 H271082 H140070 H140709 H140838 H270215 H270351 H270449 H270534 H270686 H270782 H270884 H271083 H140077 H140713 H140839 H270216 H270352 H270450 H270540 H270690 H270783 H270885 H271085 H140080 H140720 H140847 H270226 H270353 H270452 H270542 H270692 H270786 H270886 H271094 H140090 H140723 H140862 H270227 H270355 H270454 H270545 H270693 H270787 H270888 H271096 H140096 H140725 H140870 H270232 H270356 H270455 H270547 H270695 H270788 H270890 H271098 H140097 H140726 H140898 H270233 H270360 H270457 H270550 H270700 H270790 H270892 H271099 H140099 H140734 H140899 H270235 H270361 H270459 H270603 H270702 H270792 H270894 H271100  H271102 H271208 H271347 H271433 H271528 H271603 H271708 H271788 H271898 H271990 H272105 H271103 H271210 H271349 H271435 H271530 H271604 H271709 H271789 H271899 H271994 H272106 H271107 H271213 H271355 H271436 H271532 H271606 H271711 H271790 H271901 H271995 H272111 H271109 H271215 H271356 H271438 H271534 H271611 H271715 H271791 H271903 H271996 H272117 H271110 H271216 H271358 H271439 H271535 H271616 H271716 H271792 H271904 H272002 H272118 H271111 H271227 H271361 H271441 H271536 H271622 H271717 H271793 H271905 H272003 H272124 H271112 H271230 H271362 H271442 H271540 H271624 H271718 H271795 H271907 H272004 H272127 H271115 H271231 H271367 H271443 H271541 H271627 H271721 H271797 H271909 H272005 H272128 H271117 H271232 H271370 H271444 H271542 H271630 H271722 H271799 H271914 H272010 H272129 H271123 H271245 H271371 H271449 H271543 H271634 H271723 H271803 H271915 H272011 H272130 H271124 H271247 H271372 H271453 H271544 H271636 H271725 H271807 H271921 H272012 H272132 H271125 H271248 H271374 H271455 H271545 H271638 H271726 H271811 H271922 H272013 H272136 H271131 H271249 H271376 H271459 H271547 H271646 H271727 H271812 H271923 H272014 H272137 H271133 H271253 H271377 H271460 H271549 H271647 H271728 H271817 H271924 H272020 H272142 H271135 H271256 H271378 H271461 H271551 H271651 H271732 H271818 H271925 H272021 H272147 H271136 H271257 H271379 H271465 H271553 H271654 H271733 H271824 H271927 H272027 H272156 H271137 H271258 H271380 H271468 H271555 H271658 H271734 H271825 H271928 H272028 H272157 H271138 H271260 H271382 H271470 H271560 H271661 H271735 H271827 H271929 H272031 H272158 H271142 H271263 H271383 H271472 H271561 H271662 H271736 H271837 H271931 H272034 H272159 H271143 H271264 H271386 H271474 H271562 H271663 H271739 H271840 H271933 H272039 H272161 H271144 H271268 H271390 H271475 H271563 H271665 H271740 H271841 H271934 H272043 H272162 H271152 H271269 H271391 H271476 H271564 H271666 H271741 H271845 H271936 H272044 H272163 H271155 H271272 H271392 H271477 H271565 H271674 H271743 H271846 H271938 H272047 H272164 H271157 H271275 H271393 H271479 H271568 H271679 H271744 H271850 H271943 H272050 H272165 H271159 H271276 H271394 H271480 H271569 H271680 H271746 H271852 H271947 H272052 H272167 H271160 H271278 H271395 H271481 H271570 H271681 H271749 H271853 H271950 H272054 H272168 H271161 H271281 H271397 H271483 H271571 H271682 H271753 H271854 H271955 H272060 H272170 H271162 H271288 H271398 H271484 H271572 H271684 H271754 H271855 H271958 H272061 H272171 H271175 H271290 H271399 H271485 H271573 H271686 H271755 H271859 H271959 H272064 H272173 H271176 H271292 H271402 H271486 H271575 H271687 H271756 H271863 H271963 H272065 H272174 H271179 H271293 H271404 H271489 H271576 H271688 H271759 H271864 H271965 H272068 H272175 H271184 H271294 H271407 H271490 H271577 H271691 H271760 H271865 H271967 H272070 H272177 H271185 H271296 H271409 H271491 H271578 H271692 H271763 H271870 H271968 H272071 H272179 H271186 H271298 H271410 H271493 H271581 H271694 H271764 H271872 H271969 H272073 H272180 H271188 H271299 H271416 H271496 H271584 H271695 H271765 H271873 H271970 H272074 H272182 H271191 H271303 H271417 H271497 H271586 H271696 H271766 H271874 H271971 H272077 H272183 H271193 H271312 H271419 H271505 H271588 H271698 H271768 H271875 H271972 H272080 H272185 H271195 H271314 H271421 H271506 H271591 H271700 H271771 H271880 H271977 H272081 H272192 H271196 H271319 H271423 H271510 H271593 H271701 H271773 H271882 H271978 H272086 H272194 H271197 H271320 H271425 H271512 H271594 H271702 H271776 H271886 H271980 H272087 H272196 H271198 H271324 H271426 H271513 H271597 H271703 H271777 H271887 H271981 H272088 H272197 H271200 H271328 H271427 H271515 H271598 H271704 H271781 H271888 H271982 H272092 H272199 H271201 H271338 H271428 H271518 H271599 H271705 H271782 H271889 H271983 H272100 H272203 H271202 H271343 H271431 H271523 H271600 H271706 H271784 H271891 H271986 H272103 H272211 H271206 H271344 H271432 H271527 H271602 H271707 H271787 H271892 H271988 H272104 H272215 H272216 H272320 H272422 H272836 H272957 H273103 H290114 H290217 H290320 H290414 H291016 H272217 H272323 H272425 H272838 H272959 H273105 H290116 H290219 H290321 H290417 H291017 H272221 H272324 H272430 H272840 H272961 H273112 H290118 H290220 H290323 H290423 H291019 H272226 H272325 H272431 H272843 H272962 H273114 H290123 H290226 H290324 H290424 H291023 H272229 H272327 H272432 H272844 H272966 H273119 H290130 H290228 H290325 H290425 H291024 H272239 H272328 H272433 H272851 H272971 H273120 H290137 H290229 H290327 H290426 H291026 H272243 H272329 H272439 H272852 H272974 H273122 H290138 H290230 H290328 H290427 H291027 H272245 H272330 H272441 H272853 H272975 H273136 H290139 H290231 H290330 H290500 H291031 H272249 H272332 H272443 H272857 H272976 H273140 H290143 H290235 H290331 H290503 H291032 H272259 H272333 H272445 H272858 H272981 H273141 H290144 H290236 H290333 H290506 H291034 H272260 H272334 H272446 H272859 H272983 H273142 H290146 H290237 H290334 H290507 H291037 H272261 H272335 H272447 H272861 H272986 H273143 H290151 H290240 H290336 H290511 H291041 H272264 H272337 H272448 H272862 H272988 H273149 H290152 H290242 H290338 H290513 H291044 H272265 H272338 H272451 H272863 H272989 H273150 H290154 H290244 H290339 H290516 H291045 H272267 H272341 H272452 H272864 H272991 H273151 H290155 H290248 H290342 H290517 H291046 H272269 H272346 H272453 H272867 H272993 H273152 H290158 H290253 H290345 H290518 H291049 H272270 H272347 H272454 H272875 H272994 H273153 H290159 H290254 H290346 H290519 H291055 H272276 H272348 H272461 H272878 H273002 H273158 H290160 H290257 H290351 H290526 H291062 H272279 H272351 H272462 H272879 H273004 H273159 H290161 H290258 H290352 H290527 H291064 H272280 H272352 H272466 H272880 H273005 H273164 H290164 H290260 H290356 H290528 H291066 H272283 H272353 H272467 H272882 H273012 H273176 H290171 H290261 H290357 H290529 H291067 H272284 H272355 H272468 H272885 H273016 H273180 H290173 H290264 H290358 H290533 H291073 H272286 H272358 H272469 H272886 H273018 H273182 H290175 H290266 H290359 H290534 H291074 H272288 H272361 H272470 H272887 H273020 H273187 H290176 H290268 H290360 H290536 H291075 H272290 H272363 H272482 H272891 H273021 H273191 H290177 H290269 H290363 H290539 H291078 H272291 H272364 H272483 H272892 H273029 H273200 H290180 H290272 H290369 H290540 H291080 H272292 H272366 H272484 H272894 H273031 H273202 H290182 H290273 H290372 H290542 H291085 H272293 H272373 H272485 H272895 H273033 H273203 H290186 H290274 H290373 H290543 H291086 H272296 H272377 H272491 H272900 H273045 H273206 H290187 H290276 H290375 H290544 H291091 H272298 H272381 H272492 H272907 H273048 H273208 H290189 H290277 H290376 H290547 H291092 H272299 H272383 H272496 H272909 H273049 H273209 H290191 H290278 H290379 H290550 H291093 H272300 H272387 H272498 H272910 H273051 H290003 H290195 H290283 H290380 H290551 H291099 H272301 H272389 H272801 H272912 H273052 H290012 H290196 H290286 H290381 H290553 H291108 H272302 H272390 H272804 H272914 H273056 H290016 H290198 H290288 H290386 H290558 H291111 H272304 H272392 H272808 H272917 H273061 H290017 H290199 H290292 H290387 H290559 H291114 H272306 H272398 H272809 H272920 H273062 H290026 H290203 H290296 H290388 H290560 H291115 H272307 H272399 H272813 H272921 H273067 H290030 H290204 H290299 H290394 H290561 H291127 H272308 H272403 H272818 H272924 H273068 H290031 H290205 H290301 H290396 H290600 H291128 H272311 H272405 H272820 H272934 H273072 H290033 H290208 H290306 H290400 H291002 H291130 H272312 H272406 H272821 H272936 H273078 H290100 H290209 H290309 H290401 H291004 H291132 H272313 H272408 H272822 H272937 H273093 H290103 H290210 H290310 H290402 H291006 H291137 H272315 H272409 H272823 H272941 H273097 H290105 H290211 H290311 H290406 H291007 H291139 H272316 H272414 H272829 H272942 H273098 H290106 H290213 H290314 H290411 H291008 H291140 H272317 H272419 H272830 H272949 H273101 H290108 H290214 H290315 H290412 H291010 H291142 H272318 H272421 H272831 H272954 H273102 H290111 H290216 H290316 H290413 H291015 H291144 H291148 H293308 H293406 H293556 H293678 H293791 H293910 H294073 H294235 H294393 H291151 H293311 H293416 H293559 H293679 H293794 H293924 H294083 H294237 H294394 H291152 H293315 H293417 H293560 H293681 H293795 H293929 H294091 H294248 H294395 H291154 H293316 H293421 H293562 H293682 H293796 H293935 H294095 H294256 H294397 H291157 H293320 H293423 H293567 H293684 H293802 H293938 H294098 H294265 H294399 H291158 H293321 H293424 H293568 H293687 H293803 H293942 H294100 H294284 H294403 H291159 H293323 H293427 H293571 H293691 H293804 H293947 H294101 H294288 H294407 H291160 H293325 H293428 H293584 H293698 H293805 H293948 H294104 H294292 H294414 H291163 H293326 H293429 H293585 H293702 H293810 H293950 H294105 H294294 H294427 H291164 H293327 H293431 H293588 H293704 H293811 H293953 H294106 H294299 H294429 H291165 H293328 H293432 H293594 H293705 H293821 H293956 H294108 H294302 H294451 H291168 H293329 H293434 H293595 H293710 H293822 H293958 H294110 H294304 H294467 H291176 H293331 H293441 H293597 H293712 H293823 H293959 H294111 H294307 H294474 H291181 H293332 H293444 H293598 H293725 H293826 H293960 H294118 H294308 H294569 H291182 H293335 H293447 H293600 H293726 H293829 H293964 H294119 H294312 H294588 H291193 H293336 H293450 H293601 H293727 H293830 H293967 H294122 H294317 H294633 H291194 H293337 H293455 H293602 H293728 H293835 H293979 H294123 H294319 H294639 H291195 H293338 H293456 H293603 H293731 H293839 H293980 H294129 H294324 H294640 H291198 H293339 H293464 H293604 H293732 H293842 H293982 H294133 H294326 H294641 H291201 H293341 H293467 H293605 H293734 H293845 H293984 H294136 H294327 H294655 H291204 H293343 H293468 H293606 H293739 H293848 H293987 H294140 H294328 H294697 H291205 H293344 H293469 H293607 H293740 H293854 H293994 H294142 H294329 H294702 H291211 H293345 H293471 H293608 H293741 H293856 H293997 H294144 H294331 HCX4019 H291222 H293348 H293477 H293612 H293743 H293857 H293998 H294147 H294333 HCX4344 H291227 H293349 H293487 H293613 H293747 H293858 H293999 H294154 H294335 HCX4662 H291228 H293353 H293489 H293617 H293750 H293865 H294002 H294157 H294337  H291231 H293357 H293490 H293619 H293752 H293867 H294003 H294158 H294340  H291237 H293364 H293496 H293626 H293753 H293869 H294004 H294168 H294341  H291238 H293365 H293498 H293628 H293754 H293870 H294006 H294175 H294346  H291239 H293367 H293501 H293629 H293758 H293871 H294022 H294181 H294348  H291241 H293368 H293507 H293630 H293760 H293872 H294024 H294186 H294350  H291246 H293371 H293510 H293631 H293763 H293875 H294028 H294189 H294355  H291250 H293374 H293511 H293637 H293765 H293877 H294034 H294196 H294364  H291256 H293378 H293512 H293638 H293767 H293878 H294035 H294197 H294366  H291264 H293379 H293516 H293639 H293770 H293882 H294038 H294200 H294368  H291265 H293384 H293518 H293642 H293771 H293889 H294041 H294203 H294372  H291267 H293385 H293521 H293643 H293773 H293890 H294045 H294204 H294373  H291270 H293386 H293530 H293645 H293774 H293898 H294047 H294205 H294378  H291272 H293387 H293532 H293648 H293776 H293900 H294056 H294209 H294380  H293009 H293388 H293534 H293649 H293780 H293901 H294059 H294210 H294381  H293207 H293389 H293540 H293650 H293782 H293904 H294063 H294215 H294382  H293300 H293394 H293550 H293661 H293785 H293905 H294065 H294216 H294383  H293302 H293395 H293552 H293662 H293786 H293907 H294069 H294217 H294384  H293305 H293396 H293553 H293663 H293789 H293908 H294070 H294226 H294386  H293307 H293401 H293554 H293664 H293790 H293909 H294072 H294234 H294392.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Varian High Energy Linear Accelerator: || Varian Medical Systems, Palo Alto, CA 94304 || Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Dirección del fabricante
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Empresa matriz del fabricante (2017)
    Varian Medical Systems Inc
  • Source
    USFDA