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U.S. Department of Health and Human Services

Class 2 Device Recall Varian

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 Class 2 Recall
Varian
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Date Posted April 23, 2013
Recall Status1 Terminated on July 09, 2014
Recall Number Z-1163-2013
Recall Event ID 64828
Premarket Notification
510(K) Number
K102024 
Product Classification Accelerator, Linear, Medical - Product Code IYE
Product Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
Code Information CODES: HS00017 HS00366 HS00611 HS00804 HS01060 HS01256 HS01451 HS01662 HS01863 HS02024 HS02215 HS02371 HS02539 HS00018 HS00371 HS00615 HS00805 HS01061 HS01260 HS01456 HS01664 HS01872 HS02035 HS02239 HS02373 HS02542 HS00025 HS00378 HS00618 HS00806 HS01062 HS01265 HSOI459 HSOI667 HSOI875 HS02040 HS02240 HS02376 HS02545 HS00026 HS00384 HS00619 HS00807 HSOI063 HSOI269 HSOI460 HSOI671 HSOI876 HS02043 HS02242 HS02377 HS02548 HS00031 HS00385 HS00624 HS00811 HSOI066 HS01270 HSOI462 HSOI674 HSOI877 HS02048 HS02245 HS02380 HS02SSI HS00032 HS00392 HS00628 HS00813 HS01069 HSOI281 HS01463 HSOI675 HSOI878 HS02053 HS02250 HS02381 HS02553 HS00035 HS00393 HS00630 HS00814 HS01071 HSOI282 HS01466 HS01676 HS01883 HS020SS HS022Sl HS02383 HS02554 HS00036 HS00396 HS00634 HSOOSIS HS01080 HS01283 HS0147l HS01678 HS01885 HS02059 HS02253 HS02384 HS02SSS HS00037 HS00398 HS00636 HS00818 HSOIOSS HS01285 HS01480 HS01685 HS01886 HS02068 HS02256 HS02389 HS02562 HS00038 HS00408 HS00638 HS00827 HS01090 HS01291 HS01489 HS01686 HS01888 HS02070 HS02262 HS02392 HS02565 HS00039 HS00410 HS00639 HS00829 HS01093 HS01296 HSOI490 HS01694 HS01889 HS02072 HS02263 HS02395 HS02566 HS00043 HS00420 HS00640 HS00843 HS01094 HS01299 HSOI498 HS01696 HS01890 HS02080 HS02267 HS02397 HS02567 h500044 HS00422 HS0064l HS008Sl HSOllOO HS01303 HS01499 HS01697 HS01893 HS02083 HS02268 HS02399 HS02569 HS00049 HS00433 HS00643 HS00856 HSOIIOS HS01307 HSOISOO HS01698 HS01895 HS02085 HS02269 HS02401 HS02573 HSOOOSO HS00434 HS00644 HS00873 HSOI106 HS01308 HSOIS03 HS01700 HS01896 HS02087 HS02278 HS02403 HS02574 HS00073 HS00435 HS00646 HS00879 HS01108 HS013ll HSOISIO HS01704 HS01897 HS02088 HS02279 HS02406 HS02575 HS00074 HS00440 HS00649 HS00881 HS01109 HS01313 HSOISll HS01707 HS01900 HS02090 HS02280 HS02408 HS02576 HS00075 HS00443 HS00654 HS00890 HSOI113 HS01314 HSOISIS HS01708 HS01902 HS02097 HS02282 HS02409 HS02584 HS00077 HS00452 HS00664 HS00892 HSOlll9 HS01320 HSOIS25 HS01709 HS01908 HS02099 HS02283 HS024ll HS02586 HS00078 HS004SS h500666 HS00897 HSOII20 HS01324 HSOIS30 HS01710 HS01912 HS02100 HS02284 HS02418 HS02587 HS00086 HS00456 HS00669 HS00899 HSOll2l HSOI327 HS01533 HS017ll HS01913 HS02102 HS02286 HS02419 HS02596 HS00087 HS00458 HS00670 HS00900 HSOll26 HS01331 HSOIS35 HS01714 HSOI914 HS02ll4 HS02289 HS02420 HS02598 HS00088 HS00465 HS00671 HS0090l HS01128 HS01332 HSOIS39 HSOI718 HS01921 HS02116 HS02292 HS02424 HS02600 HS00089 HS00466 HS00673 HS00914 HS01130 HS01335 HSOIS41 HS01721 HS01940 HS02117 HS02293 HS02425 HS02604 HS00097 HS00467 HS00679 HS00915 HS0113l HS01338 HSOIS44 HSOI722 HS01943 HS02118 HS02294 HS02427 HS02607 HSOOIOI HS00468 HS00682 HS00927 HS01132 HS01340 HSOIS45 HSOI732 HS01944 HS0212l HS02300 HS0243l HS02612 HS00102 HS00470 HS00684 HS00930 HS01135 HSOI34l HSOIS47 HS01733 HS01948 HS02126 HS02301 HS02433 HS02613 HS00108 HS00473 HS00687 HS00933 HS01140 HSOI344 HSOIS48 HS01735 HS019Sl HS02128 HS02306 HS02440 HS02616 HSOOI20 HS00479 HS00689 HS00942 HS01141 HSOI346 HSOISSl HS01737 HS01953 HS02135 HS02309 HS02441 HS02618 HS0012l HS00481 HS00693 HS00949 HS01142 HS01350 HSOISS4 HS01744 HS019SS HS02136 HS023ll HS02442 HS02620 HSOOI30 HS00487 HS00695 HS00950 HSOll46 HS01360 HSOIS76 HS01747 HSOI956 HS02138 HS02321 HS02461 HS02621 HSOOIS7 HS00491 HS00697 HS00951 HS01147 HSOI362 HSOIS80 HS017SS HS01957 HS02140 HS02322 HS02463 HS02636 HSOOI64 HS00492 HS00703 HS00958 HSOllSl HS01372 HSOIS82 HS01756 HS01958 HS02141 HS02327 HS02464 HS02638 HS00188 HSOOS02 HS00710 HS00959 HS01160 HSOI374 HSOIS84 HS01759 HS01964 HS02146 HS02331 HS02467 HS02640 HS0019l HSOOSOS HS00715 HS00960 HSOI166 HS01379 HSOIS89 HS01763 HS01971 HS02152 HS02332 HS02474 HS02646 h500192 HSOOS24 HS00717 HS00962 HS01170 HSOI380 HSOIS92 HS01766 HS01972 HS02153 HS02333 HS02478 HS02649 HSOOI93 HSOOS34 HS00722 HS00963 HS01173 HSOI384 HSOIS93 HS01768 HS01973 HS02154 HS02335 HS02481 HS02652 h500208 HSOOS36 HS00725 HS00964 HSOll74 HS01385 H501598 H501776 H501974 H502155 H502337 H502484 H502653 HS00213 H500538 HS00727 HS00968 H501175 H501386 HS01600 HS01780 H501977 HS02163 HS02341 HS02488 H502655 H50025l H500539 HS00728 HS00973 H501178 H501387 HS01603 H501782 H501979 H502164 H502342 H502489 H502656 HS00254 HSOOS45 HS00729 HS00978 H501190 H501390 H501605 H501784 H501982 H502166 HS02344 H502495 H502661 H50026l H500548 H500730 H50098l H501193 H501392 H501606 H501790 H501983 H502168 H502345 HS02502 HS02662 H500262 H500549 H500735 HS00986 H50ll94 HS01393 HSOI608 HS01792 HS01986 H502170 H502346 H502504 HS02664 HS00271 HSOOSSO HS00736 HS00991 HS01198 HS01396 H501610 H501797 HS01988 HS02171 HS02347 HS02SOS HS02666 HS00283 HS00551 HS00749 HSOI002 H501202 H501403 H501612 H501800 H501990 H502172 HS02348 H502506 H502672 HS00286 HSOOSS7 HS007Sl HSOIOOS HS01203 HSOI410 H501616 HS01804 H501992 H502173 HS02350 H502509 HS02673 HS00287 H500561 HS00753 HS01009 HS01210 HSOI417 HS01617 H5018ll H501995 H502174 H502352 H502510 HS02674 HS00288 H500563 HS00754 HSOIOII HS01224 HS01418 HSOI622 H501815 HS02000 HS02176 HS02355 HS02513 HS02677 HS00289 HS00567 H500758 HS01012 HS01228 HS01420 H501624 HSOI819 HS02001 H502191 HS02356 HS02516 HS02680 H500294 H500573 H500759 HSOIOIS HSOI232 HSOI424 H501625 H501823 H502002 H502193 H502359 H502518 H502681 HS00303 H500574 H500762 HSOI020 HSOI233 HSOI432 HSOI631 H501824 HS02006 HS02196 H502360 H502521 H502682 H500309 H500576 H500764 HSOI034 HSOI235 HSOI434 H501633 H501832 HS02012 HS02198 H502362 H502524 HS02683 H500317 H500577 H500768 H501038 H501236 H501435 H501639 H501837 H502013 H502200 H502363 H502529 HS02684 H500321 H500579 H500775 H501040 H501240 HS01437 H501640 H501838 H502015 H502201 HS02364 H502531 H502687 H500324 H500584 HS00782 HSOI041 HSOI241 HS01439 H501646 HS01850 HS02017 H502204 H502366 HS02532 HS02688 HS00337 H500604 HS00784 HSOI044 HSOI247 HS01445 H501651 H501853 HS02018 HS02207 H502367 HS02533 HS02689 HS00340 H500605 H500787 HSOIOS6 HS01254 H501448 H501654 H501854 HS02020 HS02210 H502368 HS02536 HS02690 HS0036S HS00610 HS00796 HSOIOS8 HSOI2SS HS01449 HS01657 HS01858 HS02022 HS02214 H502369 HS02537 H50269S HS02698 HS02929 HS03074 HS03189 HS03295 H503375 HS03482 HS03571 HS03661 HS03761 HS03868 H503959 H504040 HS02703 HS02934 HS03076 HS03190 H503297 H503377 HS03483 H503572 HS03663 H503762 H503869 HS03960 H504041 HS02706 HS02936 HS03077 HS03191 HS03299 HS03378 H503486 H503573 HS03667 HS03763 H503871 HS03961 H504042 HS02707 H502937 H503078 HS03192 HS03301 HS03380 H503488 H503574 HS03668 H503764 H503872 H503963 H504043 HS02709 H502938 HS03079 HS03193 HS03302 HS03381 HS03489 HS03576 HS03669 HS03765 HS03873 H503964 HS04044 HS02715 H502943 HS03084 HS03194 H503303 HS03382 HS03492 H503577 H503670 H503766 H503874 H503965 HS04045 HS02716 H502951 H503085 H503195 H503305 H503384 H503493 H503581 H503672 HS03767 H503875 H503966 H504046 H502717 H502953 H503089 H503196 H503306 H503387 H503496 H503582 H503674 H503773 HS03876 H503967 H504047 H502718 H502956 H503090 H503203 HS03307 H503388 H503497 H503584 H503675 H503774 HS03877 H503968 H504048 H502722 H502960 H503092 H503209 H503308 H503389 H503500 H503585 H503676 H503775 H503879 HS03969 H504050 H502732 H502965 H503093 H503210 H503310 H503390 HS03501 HS03588 HS03677 H503777 H503881 HS03970 HS040Sl HS02733 HS02967 H503098 H503213 H503311 HS03391 H503503 HS03590 HS03678 HS03778 H503882 HS03971 HS04052 H502734 H502971 H503099 HS03214 HS03313 HS03392 HS03504 HS03592 H503679 HS03779 HS03883 HS03972 HS04053 H502739 HS02972 HS03100 HS03216 HS03314 HS03393 H503505 HS03593 HS03680 HS03780 HS03884 HS03974 H504054 HS02745 HS02975 HS03101 H503220 HS03315 HS03397 HS03506 HS03594 HS03682 HS03781 H503886 HS03977 HS040SS HS02749 HS02978 H503102 HS03224 H503316 H503398 H503507 HS03595 HS03683 HS03782 HS03887 HS03978 H504056 HS02750 HS02980 H503111 H503226 HS03318 HS03404 HS03508 HS03596 HS03684 HS03783 H503888 HS03979 HS04057 H502752 HS02982 HS03112 HS03227 HS03319 HS03406 H503509 HS03597 H503689 HS03786 H503889 HS03980 H504058 HS02763 HS02984 H503113 HS03228 H503320 HS03407 HS03511 HS03598 H503693 H503790 H503890 HS03982 H504060 H502765 H502985 H503114 H503229 HS03321 H503408 H503512 H503599 H503696 HS03792 H503893 HS03984 H504061 H502769 H502986 H503118 H503230 HS03322 H503409 H503513 HS03601 H503697 H503793 H503894 H503985 H504062 H502772 H502988 HS03119 H503231 HS03323 H503410 H503SIS H503602 H503698 H503794 H503895 H503986 H504063 H502774 H502989 HS03121 H503232 HS03324 H503411 H503516 HS03603 HS03700 H503798 H503897 H503987 H504064 H502775 HS02991 H503122 H503233 HS03325 HS03412 H503517 H503605 HS03704 H503799 H503898 H503988 H504066 HS02778 H502992 H503123 H503234 HS03326 HS03414 H503518 H503606 H503706 H503800 H503900 H503989 H504067 H502780 H502995 H503127 H503235 H503328 HS03418 HS03519 H503607 H503707 H503801 HS03902 HS03990 H504069 H502783 HS02996 H503128 H503239 H503330 HS03419 H503520 H503608 H503708 H503802 H503903 H503991 H504070 HS02784 HS02997 H503131 HS03240 H503331 H503420 H503522 H503609 H503709 H503803 HS03910 H503992 H504071 H502789 H502998 H503136 H503241 HS03333 HS03425 H503523 H503610 H503712 H503804 H503913 H503994 H504072 H502790 H503004 H503137 HS03242 H503335 H503426 H503527 H503611 H503713 H50380S H503914 H503996 HS04073 H502792 H503006 H503138 H503243 HS03336 H503427 H503528 HS03615 H503714 H503806 HS03915 H503999 H504074 H502796 HS03007 H503139 H503244 H503337 HS03428 H503530 H503616 H503716 H503807 H503917 H504000 H504075 H502801 H503008 H503140 H503246 H503339 H503430 H503531 H503617 HS03717 H503808 H503918 H504001 H504076 H502803 H503009 HS03142 H503247 H503340 H503431 H503534 H503618 H503719 HS03809 H503919 H504002 H504077 H502809 H503013 H503143 H503249 H503341 H503432 H503535 H503619 HS03720 HS03810 H503920 HS04004 HS04080 H502811 H503014 H503144 H503250 H503342 H503433 H503536 H503620 H503723 HS03821 H503921 H504005 H504085 HS02812 H503023 H503145 H503254 H503343 H503434 H503537 H503621 HS03724 HS03822 HS03922 H504008 HS04086 H502816 H503024 H503148 H5032SS H503345 H503436 H503538 H503624 H503726 H503825 H503923 HS04009 H504087 H502818 H503027 H503149 H503256 H503346 H503442 H503539 H503625 H503729 HS03826 H503924 H504010 H504088 H502819 H503033 H503150 HS03259 H503347 HS03444 H503541 HS03626 H503730 H503829 HS03925 H504011 H504089 H502826 HS03034 HS03151 HS03262 HS03348 HS0344S H503543 HS03627 HS03731 HS03831 H503928 HS04012 HS04090 H502832 H503036 HS03153 HS03263 HS03349 H503446 H503547 H503629 HS03733 H503834 HS03929 HS04014 H504091 HS02868 H503037 H503156 H503266 H503351 HS03449 H503548 H503630 H503734 H503836 H503930 H504015 H504092 H502874 H503039 HS03158 HS03267 H503352 H503450 H503549 HS03632 H503736 H503839 HS03934 H504016 H504093 H502876 H503041 H503159 H503269 H503355 H503451 HS03SSO H503633 H503737 H503840 H503935 H504017 H504094 H502877 H503042 H503160 H503270 H503356 H503453 H503551 H503635 HS03738 H503842 H503937 H504018 HS0409S H502881 HS03043 HS03162 H503271 H503357 H503454 HS03552 HS03636 HS03739 HS03844 HS03938 HS04020 HS04096 H502884 H503047 H503167 HS03274 HS03359 H503457 H503553 H503637 H503741 H503845 H503939 H504022 H504098 H502886 H503049 HS03168 H503275 H503360 H503458 H503554 H503640 H503742 H503846 HS03940 H504023 H504099 H502888 HS03050 H503169 HS03276 HS03361 H503460 H503555 HS03641 H503743 H503847 H503941 H504024 H504100 H502889 H503051 H503170 H503277 H503362 H503463 H503556 H503642 H503745 H503848 H503942 H504025 HS04101 HS02892 HS03053 HS03173 HS03279 HS03363 H503464 HS03557 HS03643 HS03747 H503850 H503943 H504026 H504102 H502896 H503054 HS03174 HS03280 H503364 H503466 H503558 HS03644 HS03750 H503851 H503944 HS04028 HS04103 H502897 H503056 HS03175 H503281 H503366 H503469 H503559 HS03645 HS037Sl H503852 HS03946 H504029 H504104 H502901 H503057 H503176 H503282 H503367 H503470 H503560 H503646 H503752 H503858 H503949 H504031 HS04106 HS02905 H503060 H503177 H503283 HS03368 HS03471 HS03561 HS03647 H503754 HS03860 HS039SO H504032 HS04107 HS02907 HS03061 H503180 H503284 H503369 HS03475 H503562 H503648 H503755 H503861 H503951 H504034 H504108 H502911 H503063 H503181 H503285 H503370 H503476 H503564 H503649 H503756 H503862 HS03953 H504035 H504109 H502916 H503064 H503183 H503286 H503371 H503477 H503566 H503650 H503757 H503863 H503954 H504036 H504110 H502920 H503067 H503185 H503287 H503372 H503479 H503567 H503652 H503758 H503864 H503955 H504037 H504113 H502923 H503069 H503187 H503288 H503373 H503480 H503568 H503653 H503759 H50386S HS03956 H504038 H504115 HS02928 HS03073 HS03188 H503289 HS03374 H503481 HS03569 H503658 HS03760 H503866 HS03957 H504039 H504118 H504121 HS04214 H504319 H504407 HS04524 HS04645 HS04750 H504851 H5049SO HSOS060 H505173 HS05267 HSOS399 H504122 HS04215 H504320 H504408 HS04525 HS04646 H5047SI H504853 H504952 HSOS062 HSOSI74 HS05268 HSOS402 HS04124 HS04216 H504321 H504409 HS04526 H504647 H504752 HS04854 H504954 HSOS065 HS05175 H505269 HSOS406 HS04126 HS04218 HS04322 H504410 H504527 H504649 HS04756 HS048SS HS049SS HSOS066 H505176 HSOS27S HS05408 H504128 H504220 HS04323 H504411 HS04529 HS046SI H504760 H504856 H504960 H505069 H505177 HS05276 H505412 HS04130 HS04224 H504324 H504413 HS04533 H504652 H504761 H504857 H504961 H505070 H505178 HSOS277 H505413 HS04131 HS0422S HS0432S H504418 HS04535 HS04655 H504762 H504858 HS04962 H505071 H505179 HS05278 HSOS414 HS04133 HS04227 H504326 H504420 HS04538 H504656 H504763 HS04861 HS0496S HSOS073 H505180 HS05280 HSOS417 HS04134 HS04232 HS04327 H504422 HS04541 H504659 H504764 H504864 HS04967 HSOS074 HS05184 H505286 HSOS422 HS04135 H504234 HS04328 H504423 HS04543 H504661 H504766 H504866 H504970 HSOS075 HS05186 HS05289 HSOS423 HS04136 H504236 H504329 H50442S H504545 H504662 HS04769 H504867 HS04971 H505078 H505187 HS05290 HSOS427 HS04138 H504239 HS04330 H504426 H504549 H504663 HS04770 HS04868 HS04972 H505080 HSOSI88 HSOS291 HSOS428 HS04141 HS04240 H504333 HS04428 HS04SS4 HS04666 HS04771 H504869 HS04975 HSOS081 HSOS190 HS05292 H505429 HS04144 HS04241 HS0433S HS04429 HS04556 HS04667 H504773 HS04870 HS04976 HS05082 HS05191 HS05293 HSOS430 HS04145 HS04244 HS04336 HS04432 HS04SS7 HS04668 H504774 HS04871 H504980 HSOS08S H505192 HS05294 HSOS433 HS04146 H504245 H504338 H504434 H504559 H504669 HS04778 HS04873 HS04982 HSOS087 HSOSI94 HSOS296 HSOS435 HS04147 HS04248 HS04340 H504436 H504560 HS04670 H504779 HS04874 HS04984 HSOS088 HSOS19S HSOS302 H505436 HS04148 H504249 H504342 H504437 H504561 HS04671 HS04780 HS04877 HS04989 HSOS092 HS05196 HS05303 HS05440 H504149 HS04250 H504343 H504439 HS04564 HS04672 H504782 HS04878 HS04990 HSOS094 HSOS198 HS05304 H505441 HS04152 HS04251 HS04344 H504440 HS0456S HS04673 HS04784 HS04879 H504991 HSOS09S HSOS199 HSOS306 H505442 H504153 H504252 HS0434S HS04441 HS04566 HS04674 H504785 HS04880 HS04993 HSOS096 HS05200 HSOS308 HSOS444 HS04154 HS04253 HS04346 HS04443 HS04567 HS0467S H504786 HS04883 HS0499S HSOS097 HSOS201 HSOS309 H505445 H5041SS HS04254 H504348 HS04444 H504573 HS04676 HS04787 H504884 H504996 H505099 H505203 HSOSJIO HSOS446 H504156 HS04255 HS04349 HS0444S HS04574 H504677 HS04789 H504886 HS04997 HSOSI02 HSOS204 HSOS317 HSOS447 HS04157 HS04256 HS043SO HS04446 HS04577 HS04678 HS04791 HS04889 HS04998 HSOS103 HSOS205 HS05319 HSOS448 H504158 HS04257 HS04353 HS04448 HS04578 HS04679 HS04792 HS04890 HSOSOOO HSOSIOS HSOS207 HSOS320 HSOS4SO HS04159 HS04258 HS04356 HS04449 HS04579 HS04680 HS04794 HS04892 HSOSOOI HSOS106 HSOS208 HSOS321 HSOS4Sl H504161 HS04261 HS04357 HS044SO HS04580 HS04681 HS0479S HS04894 HSOS002 HSOS121 HSOS209 HSOS326 HSOS453 HS04166 HS04263 HS043S8 HS044Sl HS04581 HS04682 HS04798 HS0489S HSOSOOJ H505122 HSOS211 HSOS329 HSOS456 HS04168 HS04264 HS04360 HS04452 HS04586 H504687 HS04800 HS04898 HSOS004 HSOS123 HSOS212 HS05330 HS05457 HS04169 HS0426S HS04361 HS04453 HS04587 HS04689 HS04801 HS04899 HSOSOOS HSOS12S HSOS214 HSOS331 HSOS458 H504170 HS04266 HS04362 HS04454 HS04594 HS04690 HS04802 HS04900 HSOS006 HSOS126 HSOS216 HSOSJJS HSOS460 HS04171 HS04268 HS04364 HS044SS HS04597 HS04692 H504803 HS04905 HSOS008 HSOSI27 HSOS217 HSOS336 HSOS461 HS04172 HS04269 HS04367 HS04460 HS04601 HS04694 HS04804 HS04906 HSOS009 HSOSI28 HSOS218 HSOS338 H505463 HS04173 HS04270 HS04368 HS04461 HS04603 HS0469S HS04806 HS04907 HSOSOIO HSOSIJO HSOS220 HSOS339 HSOS466 HS04174 HS04271 HS04369 HS04462 HS04604 H504697 HS04808 HS04908 HSOSOII HSOSI32 HSOS229 HS05343 HSOS467 H50417S HS04272 HS04370 HS04464 HS04607 H504702 H504809 HS04911 HSOSOI2 HSOSI33 HSOS232 HSOS344 HSOS468 H504176 HS04273 HS04371 HS04470 HS04608 HS04703 HS04810 HS04912 HSOSOI3 HSOS138 HSOS233 HSOS34S HSOS472 HS04177 HS04274 HS04372 H504472 H504610 HS0470S HS04811 HS04913 HS05014 HSOS140 HSOS234 HSOS346 HSOS473 HS04178 HS04275 HS04373 HS04473 HS04611 HS04706 HS04812 HS04914 HSOSOIS HSOSI41 H505236 HSOS347 HSOS477 HS04179 HS04276 HS04374 HS04475 HS04612 HS04707 HS0481S HS04916 HSOS017 HSOS142 HSOS238 HSOS348 HSOS496 HS04180 'HS04278 HS04375 HS04477 HS04614 H504708 HS04816 H504917 H505018 H505144 HSOS239 H505349 HS05498 HS04181 HS04282 HS04377 HS04480 H504616 HS04711 HS04817 H504919 HSOS019 H50514S H505240 H505350 HSOSSOO HS04182 HS04283 HS04378 HS04481 HS04617 H504713 HS04823 HS04920 HSOS020 H50Sl46 HSOS241 H505351 HSOSSOJ HS04183 H504284 H504380 HS04482 H504618 HS04717 HS04824 HS04921 HSOS021 H50Sl47 HSOS242 HSOS352 HSOSS04 HS04184 HS0428S HS04383 HS0448S HS04620 HS04724 HS04829 HS04924 HSOS022 HSOSI48 HSOS243 HSOSJSJ HSOSSOS HS0418S HS04287 HS04387 HS04486 HS04621 HS04726 HS04830 HS04925 HSOS023 HSOSISO HSOS244 HSOSJSS HSOSS06 HS04186 HS04289 HS04388 H504488 HS04622 HS04727 HS04831 HS04926 HSOS02S HSOSISI HSOS24S HS05357 H505507 H504187 H504292 HS04390 HS04490 HS04623 H504728 HS04832 HS04927 H505026 H505153 H505247 HSOS361 HS05508 HS04192 H504293 H504391 H504494 HS04624 H504729 HS04833 H504928 H505027 HSOSIS6 H505248 HSOS36S H505513 H504194 HS04297 H504392 H504498 H504628 H504730 HS04834 H504930 H505028 H505157 H505249 HS05372 HSOS514 HS04197 H504298 H504393 H504499 H504630 HS04733 H504835 H504934 HSOS031 HSOS158 H505250 H505373 HSOSSIS H504198 H504300 HS04394 HS04500 H504631 H504734 H504837 H504936 HSOS033 H505161 HS05251 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Recalling Firm/
Manufacturer
Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto, California 94304-1028
For Additional Information Contact Patricia A. Erwin
650-424-5731
Manufacturer Reason
for Recall
Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
FDA Determined
Cause 2
DESIGN: Device Design
Action Varian sent an Urgent Medical Device Correction - Urgent Field Safety Notice Letter dated March 26, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to retain a copy of this document along with their most current product labeling, advise the appropriate personnel of the content of this letter, and for future reference this document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. The letter stated that a Varian Medical Systems has developed a technical correction and a Customer Service representative will contact customers to schedule installation. For question contact your local Varian medical Systems Customer Support District or Regional Manager.
Quantity in Commerce 2508 units
Distribution Worldwide Distribution - USA (Nationwide) and countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab E, and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS
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