Device Recall Varian

Version Numbers 6.2.27 and 6.2.35, 510k number K001643, serial numbers H8__ (31901, 50044, 50149, 50181, 50187,50260, 50284, 50315, 50357, 50397, 50430, 50804, 50873, 51096, 51152, 51186, 51082, 51463, 51534, 51580, 51658, 51773, 51787, 59032, 59040, 59041, 59045)

Radiology Devices

2

No

produt was distributed to 28 medical facilities, 12 in the United states, 16 foreign

medical device and software systems

Model numbers H14, H27 and H29. Serial numbers: H140012 H140889 H140900 H140910 H140920 H140766 H140890 H140901 H140911 H140921 H140809 H140891 H140902 H140912 H140923 H140815 H140892 H140903 H140913 H140924 H140838 H140893 H140904 H140914 H140925 H140851 H140895 H140905 H140915 H140926 H140876 H140896 H140906 H140916 H140927 H140886 H140897 H140907 H140917 H140929 H140887 H140898 H140908 H140918 H140930 H140888 H140899 H140909 H140919 H140932 H270817 H271430 H271893 H272242 H290255 H271038 H271435 H271932 H272246 H290415 H271105 H271447 H271949 H272323 H291177 H271198 H271462 H271961 H272396  H271201 H271516 H271975 H272400  H271214 H271521 H271991 H272423  H271250 H271618 H272107 H272445  H271280 H271761 H272125 H272480  H271302 H271843 H272140 H290034  H271311 H271889 H272238 H290192

Radiology Devices

2

No

Worldwide Distribution -- USA (nationwide) and countries of: Australia, Columbia, Denmark, France, Ireland, Italy, Japan, Morocco, Poland, Portugal, Saudi Arabia, South Korea, Spain, and United Kingdom.

Clinac Linear Accelerator; || Model numbers H14, H27 and H29. || Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

,H140002 ,H140087 ,H180135 , H180273 ,H180463 ,H180554 , H180623 ,H180685 ,H180747 , H180809 ,H180868 ,H181026 , H181085, H140003 ,H140089 , H180143 , H180274 ,H180466 ,H180555 ,H180624 ,H180686 ,H180748 ,H180810 ,H180869 ,H181027 ,H181086 ,H140004 ,H140091 ,H180144 ,H180275 ,H180467 ,H180556 ,H180625 ,H180687 ,H180749 ,H180811 ,H180870 ,H181028 ,H181087 ,H140005 ,H140093 ,H180148 ,H180283 ,H180469 ,H180559 ,H180626 ,H180688 ,H180750 ,H180812 ,H180871 ,H181029 ,H181088 ,H140006 ,H140094 ,H180157 ,H180287 ,H180470 ,H180560 ,H180627 ,H180689 ,H180751 ,H180813 ,H180872 ,H181030 ,H181089 ,H140007 ,H140095 ,H180159 ,H180290 ,H180471 ,H180561 ,H180628 ,H180690 ,H180752 ,H180814 ,H180873 ,H181031 ,H181090 ,H140008 ,H140099 ,H180161 ,H180291 ,H180472 ,H180562 ,H180629 ,H180691 ,H180753 ,H180815 ,H180874 ,H181032 ,H181091 ,H140009 ,H140100 ,H180166 ,H180292 ,H180473 ,H180564 ,H180630 ,H180692 ,H180754 ,H180816 ,H180875 ,H181033 ,H181092 ,H140010 ,H140102 ,H180167 ,H180293 ,H180474 ,H180566 ,H180631 ,H180694 ,H180755 ,H180817 ,H180876 ,H181034 ,H181093 ,H140012 ,H140103 ,H180171 ,H180294 ,H180475 ,H180568 ,H180632 ,H180695 ,H180756 ,H180818 ,H180877 ,H181035 ,H181094 ,H140014 ,H140105 ,H180175 ,H180295 ,H180476 ,H180569 ,H180633 ,H180696 ,H180757 ,H180819 ,H180878 ,H181036 ,H181095 ,H140015 ,H140106 ,H180178 ,H180296 ,H180477 ,H180570 ,H180634 ,H180697 ,H180758 ,H180820 ,H180879 ,H181037 ,H181096 ,H140016 ,H140108 ,H180179 ,H180298 ,H180478 ,H180572 ,H180635 ,H180698 ,H180759 ,H180821 ,H180880 ,H181038 ,H181097 ,H140017 ,H140110 ,H180181 ,H180307 ,H180480 ,H180573 ,H180636 ,H180699 ,H180760 ,H180822 ,H180881 ,H181039 ,H181098 ,H140019 ,H140112 ,H180182 ,H180309 ,H180482 ,H180574 ,H180637 ,H180700 ,H180761 ,H180823 ,H180882 ,H181040 ,H181099 ,H140021 ,H140120 ,H180186 ,H180311 ,H180484 ,H180575 ,H180638 ,H180701 ,H180762 ,H180824 ,H180883 ,H181041 ,H181100 ,H140022 ,H140123 ,H180192 ,H180312 ,H180485 ,H180576 ,H180639 ,H180702 ,H180763 ,H180825 ,H180884 ,H181042 ,H181101 ,H140023 ,H140126 ,H180193 ,H180314 ,H180486 ,H180577 ,H180640 ,H180703 ,H180764 ,H180826 ,H180885 ,H181043 ,H181102 ,H140024 ,H140127 ,H180197 ,H180318 ,H180487 ,H180578 ,H180641 ,H180704 ,H180765 ,H180827 ,H180886 ,H181044 ,H181103 ,H140028 ,H140128 ,H180199 ,H180319 ,H180489 ,H180581 ,H180642 ,H180705 ,H180766 ,H180828 ,H180887 ,H181045 ,H181104 ,H140030 ,H140130 ,H180201 ,H180322 ,H180491 ,H180582 ,H180643 ,H180706 ,H180767 ,H180829 ,H180888 ,H181046 ,H181105 ,H140032 ,H140131 ,H180203 ,H180323 ,H180492 ,H180583 ,H180644 ,H180707 ,H180768 ,H180830 ,H180890 ,H181047 ,H181106 ,H140033 ,H180003 ,H180204 ,H180328 ,H180493 ,H180584 ,H180645 ,H180708 ,H180769 ,H180831 ,H180891 ,H181048 ,H181107 ,H140034 ,H180004 ,H180208 ,H180329 ,H180494 ,H180585 ,H180646 ,H180709 ,H180770 ,H180832 ,H180892 ,H181049 ,H181108 ,H140035 ,H180007 ,H180209 ,H180404 ,H180498 ,H180587 ,H180647 ,H180710 ,H180771 ,H180833 ,H180894 ,H181050 ,H181109 ,H140036 ,H180008 ,H180210 ,H180405 ,H180499 ,H180588 ,H180649 ,H180711 ,H180772 ,H180834 ,H180895 ,H181051 ,H181110 ,H140037 ,H180016 ,H180214 ,H180406 ,H180501 ,H180589 ,H180650 ,H180713 ,H180773 ,H180835 ,H180896 ,H181052 ,H181111 ,H140040 ,H180019 ,H180215 ,H180407 ,H180507 ,H180590 ,H180651 ,H180714 ,H180774 ,H180836 ,H180897 ,H181053 ,H181112 ,H140041 ,H180025 ,H180217 ,H180409 ,H180509 ,H180591 ,H180652 ,H180715 ,H180775 ,H180837 ,H180898 ,H181055 ,H181113 ,H140042 ,H180028 ,H180218 ,H180411 ,H180510 ,H180592 ,H180653 ,H180716 ,H180776 ,H180838 ,H180899 ,H181056 ,H181114 ,H140044 ,H180040 ,H180220 ,H180412 ,H180511 ,H180593 ,H180654 ,H180717 ,H180777 ,H180839 ,H180901 ,H181057 ,H181115 ,H140049 ,H180043 ,H180221 ,H180414 ,H180514 ,H180594 ,H180655 ,H180718 ,H180778 ,H180840 ,H180907 ,H181058 ,H181116 ,H140050 ,H180044 ,H180222 ,H180417 ,H180515 ,H180595 ,H180656 ,H180719 ,H180779 ,H180841 ,H181000 ,H181059 ,H181117 ,H140051 ,H180048 ,H180225 ,H180420 ,H180517 ,H180596 ,H180657 ,H180720 ,H180780 ,H180842 ,H181001 ,H181060 ,H181118 ,H140052 ,H180049 ,H180226 ,H180424 ,H180518 ,H180597 ,H180658 ,H180721 ,H180781 ,H180843 ,H181002 ,H181061 ,H181119 ,H140053 ,H180050 ,H180228 ,H180425 ,H180519 ,H180598 ,H180659 ,H180722 ,H180782 ,H180844 ,H181003 ,H181062 ,H181120 ,H140054 ,H180052 ,H180229 ,H180426 ,H180520 ,H180599 ,H180660 ,H180723 ,H180783 ,H180845 ,H181004 ,H181063 ,H181121 ,H140055 ,H180056 ,H180233 ,H180427 ,H180521 ,H180600 ,H180661 ,H180724 ,H180784 ,H180847 ,H181005 ,H181064 ,H181123 ,H140056 ,H180058 ,H180235 ,H180433 ,H180522 ,H180601 ,H180662 ,H180725 ,H180785 ,H180848 ,H181006 ,H181065 ,H181124 ,H140057 ,H180059 ,H180236 ,H180434 ,H180527 ,H180602 ,H180663 ,H180726 ,H180786 ,H180849 ,H181007 ,H181066 ,H181125 ,H140059 ,H180065 ,H180237 ,H180437 ,H180528 ,H180603 ,H180664 ,H180727 ,H180788 ,H180850 ,H181008 ,H181067 ,H181126 ,H140060 ,H180066 ,H180238 ,H180440 ,H180529 ,H180604 ,H180665 ,H180729 ,H180789 ,H180851 ,H181009 ,H181068 ,H181127 ,H140061 ,H180073 ,H180240 ,H180441 ,H180532 ,H180605 ,H180667 ,H180730 ,H180791 ,H180852 ,H181010 ,H181069 ,H181128 ,H140063 ,H180080 ,H180242 ,H180442 ,H180533 ,H180606 ,H180669 ,H180731 ,H180792 ,H180853 ,H181011 ,H181070 ,H181129 ,H140064 ,H180083 ,H180243 ,H180444 ,H180534 ,H180607 ,H180670 ,H180733 ,H180793 ,H180854 ,H181012 ,H181071 ,H181130 ,H140065 ,H180087 ,H180245 ,H180445 ,H180535 ,H180608 ,H180671 ,H180734 ,H180794 ,H180855 ,H181013 ,H181072 ,H181132 ,H140066 ,H180098 ,H180249 ,H180446 ,H180536 ,H180610 ,H180672 ,H180735 ,H180796 ,H180856 ,H181014 ,H181073 ,H181133 ,H140068 ,H180099 ,H180250 ,H180447 ,H180538 ,H180611 ,H180673 ,H180736 ,H180798 ,H180857 ,H181015 ,H181074 ,H181134 ,H140069 ,H180102 ,H180254 ,H180449 ,H180539 ,H180612 ,H180674 ,H180737 ,H180799 ,H180858 ,H181016 ,H181075 ,H181135 ,H140072 ,H180103 ,H180255 ,H180450 ,H180541 ,H180614 ,H180675 ,H180738 ,H180800 ,H180859 ,H181017 ,H181076 ,H181136 ,H140074 ,H180104 ,H180256 ,H180451 ,H180542 ,H180615 ,H180676 ,H180739 ,H180801 ,H180860 ,H181018 ,H181077 ,H181137 ,H140075 ,H180107 ,H180257 ,H180453 ,H180543 ,H180616 ,H180678 ,H180740 ,H180802 ,H180861 ,H181019 ,H181078 ,H181138 ,H140080 ,H180115 ,H180258 ,H180454 ,H180544 ,H180617 ,H180679 ,H180741 ,H180803 ,H180862 ,H181020 ,H181079 ,H181139 ,H140082 ,H180116 ,H180260 ,H180456 ,H180548 ,H180618 ,H180680 ,H180742 ,H180804 ,H180863 ,H181021 ,H181080 ,H181140 ,H140083 ,H180117 ,H180262 ,H180457 ,H180549 ,H180619 ,H180681 ,H180743 ,H180805 ,H180864 ,H181022 ,H181081 ,H181141 ,H140084 ,H180122 ,H180268 ,H180459 ,H180550 ,H180620 ,H180682 ,H180744 ,H180806 ,H180865 ,H181023 ,H181082 ,H181142 ,H140085 ,H180124 ,H180271 ,H180460 ,H180551 ,H180621 ,H180683 ,H180745 ,H180807 ,H180866 ,H181024 ,H181083 ,H181143 ,H140086 ,H180129 ,H180272 ,H180462 ,H180553 ,H180622 ,H180684 ,H180746 ,H180808 ,H180867 ,H181025 ,H181084 ,H181145    ,H181146 ,H181210 ,H270260 ,H270447 ,H270634 ,H270783 ,H270894 ,H271101 ,H271225 ,H271320 ,H271409 ,H271499 ,H271575 ,H181147 ,H181211 ,H270261 ,H270451 ,H270635 ,H270785 ,H270895 ,H271102 ,H271228 ,H271322 ,H271410 ,H271500 ,H271576 ,H181148 ,H181212 ,H270267 ,H270452 ,H270639 ,H270787 ,H270897 ,H271103 ,H271229 ,H271325 ,H271411 ,H271501 ,H271577 ,H181149 ,H181214 ,H270271 ,H270454 ,H270641 ,H270789 ,H270898 ,H271104 ,H271231 ,H271327 ,H271412 ,H271503 ,H271578 ,H181150 ,H181215 ,H270273 ,H270455 ,H270644 ,H270793 ,H270899 ,H271107 ,H271233 ,H271328 ,H271415 ,H271504 ,H271580 ,H181151 ,H181218 ,H270277 ,H270458 ,H270645 ,H270796 ,H271000 ,H271108 ,H271234 ,H271329 ,H271416 ,H271505 ,H271581 ,H181152 ,H181220 ,H270280 ,H270461 ,H270646 ,H270800 ,H271002 ,H271109 ,H271235 ,H271330 ,H271417 ,H271506 ,H271583 ,H181153 ,H181222 ,H270281 ,H270462 ,H270647 ,H270801 ,H271004 ,H271110 ,H271236 ,H271331 ,H271419 ,H271508 ,H271584 ,H181154 ,H181223 ,H270282 ,H270464 ,H270649 ,H270803 ,H271005 ,H271111 ,H271238 ,H271332 ,H271421 ,H271509 ,H271586 ,H181155 ,H181224 ,H270285 ,H270466 ,H270651 ,H270804 ,H271009 ,H271113 ,H271239 ,H271333 ,H271422 ,H271510 ,H271589 ,H181156 ,H181225 ,H270290 ,H270470 ,H270652 ,H270805 ,H271013 ,H271114 ,H271241 ,H271336 ,H271423 ,H271511 ,H271590 ,H181157 ,H181228 ,H270297 ,H270473 ,H270653 ,H270806 ,H271015 ,H271115 ,H271245 ,H271337 ,H271424 ,H271512 ,H271591 ,H181158 ,H181230 ,H270302 ,H270474 ,H270654 ,H270812 ,H271016 ,H271116 ,H271247 ,H271338 ,H271426 ,H271513 ,H271592 ,H181159 ,H189999 ,H270303 ,H270476 ,H270656 ,H270813 ,H271017 ,H271120 ,H271248 ,H271339 ,H271428 ,H271514 ,H271595 ,H181160 ,H260916 ,H270307 ,H270477 ,H270660 ,H270817 ,H271019 ,H271121 ,H271250 ,H271340 ,H271430 ,H271516 ,H271596 ,H181161 ,H260917 ,H270310 ,H270479 ,H270661 ,H270820 ,H271020 ,H271127 ,H271251 ,H271342 ,H271431 ,H271517 ,H271597 ,H181162 ,H260923 ,H270314 ,H270482 ,H270662 ,H270821 ,H271021 ,H271132 ,H271256 ,H271344 ,H271434 ,H271518 ,H271598 ,H181163 ,H260926 ,H270323 ,H270483 ,H270664 ,H270822 ,H271023 ,H271135 ,H271257 ,H271345 ,H271435 ,H271520 ,H271599 ,H181164 ,H260932 ,H270324 ,H270486 ,H270665 ,H270823 ,H271024 ,H271137 ,H271259 ,H271347 ,H271436 ,H271521 ,H271600 ,H181165 ,H260938 ,H270332 ,H270487 ,H270667 ,H270825 ,H271025 ,H271141 ,H271260 ,H271349 ,H271437 ,H271522 ,H271601 ,H181166 ,H260939 ,H270335 ,H270489 ,H270669 ,H270826 ,H271026 ,H271142 ,H271263 ,H271350 ,H271441 ,H271525 ,H271603 ,H181167 ,H260944 ,H270338 ,H270490 ,H270670 ,H270827 ,H271029 ,H271143 ,H271264 ,H271351 ,H271442 ,H271527 ,H271604 ,H181168 ,H260947 ,H270341 ,H270491 ,H270675 ,H270828 ,H271031 ,H271144 ,H271266 ,H271355 ,H271444 ,H271528 ,H271605 ,H181170 ,H270010 ,H270344 ,H270495 ,H270681 ,H270829 ,H271032 ,H271145 ,H271267 ,H271356 ,H271445 ,H271529 ,H271606 ,H181171 ,H270021 ,H270345 ,H270498 ,H270682 ,H270833 ,H271034 ,H271149 ,H271269 ,H271357 ,H271447 ,H271530 ,H271608 ,H181172 ,H270026 ,H270351 ,H270499 ,H270684 ,H270836 ,H271035 ,H271151 ,H271270 ,H271358 ,H271448 ,H271532 ,H271609 ,H181173 ,H270027 ,H270352 ,H270500 ,H270686 ,H270837 ,H271037 ,H271152 ,H271272 ,H271359 ,H271449 ,H271533 ,H271610 ,H181174 ,H270029 ,H270353 ,H270501 ,H270690 ,H270838 ,H271038 ,H271154 ,H271273 ,H271360 ,H271450 ,H271535 ,H271611 ,H181175 ,H270030 ,H270356 ,H270502 ,H270692 ,H270840 ,H271039 ,H271155 ,H271274 ,H271361 ,H271451 ,H271536 ,H271612 ,H181176 ,H270038 ,H270360 ,H270503 ,H270693 ,H270842 ,H271042 ,H271161 ,H271276 ,H271363 ,H271453 ,H271537 ,H271613 ,H181177 ,H270045 ,H270364 ,H270504 ,H270698 ,H270844 ,H271043 ,H271166 ,H271280 ,H271364 ,H271454 ,H271538 ,H271614 ,H181178 ,H270047 ,H270370 ,H270505 ,H270699 ,H270846 ,H271044 ,H271172 ,H271281 ,H271365 ,H271456 ,H271539 ,H271615 ,H181179 ,H270073 ,H270371 ,H270511 ,H270700 ,H270852 ,H271051 ,H271178 ,H271282 ,H271366 ,H271457 ,H271540 ,H271616 ,H181180 ,H270079 ,H270373 ,H270512 ,H270705 ,H270854 ,H271052 ,H271182 ,H271283 ,H271367 ,H271458 ,H271541 ,H271617 ,H181181 ,H270088 ,H270378 ,H270513 ,H270708 ,H270857 ,H271055 ,H271183 ,H271284 ,H271368 ,H271459 ,H271542 ,H271619 ,H181182 ,H270096 ,H270383 ,H270516 ,H270710 ,H270858 ,H271056 ,H271184 ,H271285 ,H271369 ,H271461 ,H271543 ,H271620 ,H181183 ,H270101 ,H270384 ,H270518 ,H270714 ,H270859 ,H271059 ,H271185 ,H271287 ,H271371 ,H271462 ,H271544 ,H271621 ,H181184 ,H270106 ,H270385 ,H270520 ,H270716 ,H270861 ,H271061 ,H271189 ,H271289 ,H271372 ,H271464 ,H271545 ,H271622 ,H181185 ,H270110 ,H270386 ,H270522 ,H270718 ,H270863 ,H271062 ,H271190 ,H271290 ,H271374 ,H271465 ,H271546 ,H271627 ,H181187 ,H270111 ,H270391 ,H270525 ,H270719 ,H270864 ,H271063 ,H271191 ,H271291 ,H271375 ,H271466 ,H271547 ,H271629 ,H181188 ,H270118 ,H270392 ,H270526 ,H270725 ,H270865 ,H271067 ,H271192 ,H271292 ,H271376 ,H271467 ,H271548 ,H271630 ,H181189 ,H270126 ,H270395 ,H270529 ,H270726 ,H270866 ,H271068 ,H271193 ,H271294 ,H271377 ,H271468 ,H271550 ,H271631 ,H181190 ,H270134 ,H270398 ,H270532 ,H270727 ,H270867 ,H271071 ,H271195 ,H271295 ,H271379 ,H271470 ,H271551 ,H271632 ,H181191 ,H270138 ,H270399 ,H270535 ,H270728 ,H270868 ,H271072 ,H271197 ,H271296 ,H271380 ,H271472 ,H271552 ,H271633 ,H181192 ,H270201 ,H270401 ,H270539 ,H270732 ,H270869 ,H271073 ,H271198 ,H271297 ,H271381 ,H271473 ,H271553 ,H271634 ,H181193 ,H270209 ,H270410 ,H270540 ,H270733 ,H270871 ,H271075 ,H271199 ,H271298 ,H271382 ,H271474 ,H271554 ,H271636 ,H181194 ,H270211 ,H270416 ,H270542 ,H270735 ,H270872 ,H271076 ,H271200 ,H271299 ,H271383 ,H271475 ,H271555 ,H271637 ,H181195 ,H270215 ,H270418 ,H270544 ,H270737 ,H270873 ,H271080 ,H271201 ,H271300 ,H271384 ,H271476 ,H271557 ,H271638 ,H181196 ,H270216 ,H270419 ,H270550 ,H270739 ,H270875 ,H271082 ,H271204 ,H271302 ,H271386 ,H271477 ,H271558 ,H271639 ,H181197 ,H270219 ,H270421 ,H270601 ,H270746 ,H270877 ,H271083 ,H271205 ,H271303 ,H271387 ,H271478 ,H271561 ,H271641 ,H181198 ,H270227 ,H270425 ,H270602 ,H270749 ,H270878 ,H271085 ,H271207 ,H271304 ,H271388 ,H271479 ,H271562 ,H271642 ,H181199 ,H270228 ,H270426 ,H270606 ,H270751 ,H270879 ,H271086 ,H271208 ,H271305 ,H271389 ,H271481 ,H271563 ,H271643 ,H181200 ,H270229 ,H270427 ,H270607 ,H270752 ,H270880 ,H271088 ,H271209 ,H271306 ,H271390 ,H271483 ,H271564 ,H271645 ,H181201 ,H270230 ,H270428 ,H270613 ,H270755 ,H270882 ,H271091 ,H271210 ,H271307 ,H271392 ,H271484 ,H271565 ,H271646 ,H181202 ,H270232 ,H270430 ,H270615 ,H270757 ,H270883 ,H271092 ,H271211 ,H271309 ,H271395 ,H271485 ,H271566 ,H271647 ,H181203 ,H270235 ,H270431 ,H270622 ,H270761 ,H270884 ,H271093 ,H271212 ,H271312 ,H271398 ,H271487 ,H271567 ,H271648 ,H181204 ,H270244 ,H270435 ,H270623 ,H270762 ,H270885 ,H271094 ,H271216 ,H271314 ,H271399 ,H271488 ,H271568 ,H271649 ,H181205 ,H270245 ,H270437 ,H270624 ,H270763 ,H270886 ,H271095 ,H271217 ,H271315 ,H271401 ,H271492 ,H271570 ,H271650 ,H181206 ,H270251 ,H270438 ,H270625 ,H270766 ,H270888 ,H271097 ,H271218 ,H271316 ,H271402 ,H271493 ,H271571 ,H271651 ,H181207 ,H270252 ,H270439 ,H270627 ,H270777 ,H270889 ,H271098 ,H271222 ,H271317 ,H271403 ,H271494 ,H271572 ,H271652 ,H181208 ,H270255 ,H270443 ,H270631 ,H270781 ,H270891 ,H271099 ,H271223 ,H271318 ,H271404 ,H271495 ,H271573 ,H271653 ,H181209 ,H270256 ,H270446 ,H270632 ,H270782 ,H270892 ,H271100 ,H271224 ,H271319 ,H271406 ,H271498 ,H271574 ,H271654   ,H271655 ,H271739 ,H271816 ,H271901 ,H271983 ,H272071 ,H272149 ,H272251 ,H272348 ,H272447 ,H272865 ,H272957 ,H273062 ,H271656 ,H271740 ,H271817 ,H271902 ,H271984 ,H272072 ,H272150 ,H272253 ,H272350 ,H272448 ,H272867 ,H272958 ,H273067 ,H271657 ,H271741 ,H271818 ,H271904 ,H271985 ,H272073 ,H272151 ,H272254 ,H272351 ,H272449 ,H272869 ,H272959 ,H273068 ,H271658 ,H271743 ,H271819 ,H271907 ,H271986 ,H272074 ,H272152 ,H272255 ,H272352 ,H272450 ,H272870 ,H272962 ,H273069 ,H271659 ,H271744 ,H271820 ,H271908 ,H271987 ,H272075 ,H272154 ,H272256 ,H272353 ,H272451 ,H272871 ,H272965 ,H273070 ,H271660 ,H271746 ,H271821 ,H271909 ,H271988 ,H272076 ,H272160 ,H272257 ,H272356 ,H272452 ,H272875 ,H272966 ,H273071 ,H271666 ,H271747 ,H271822 ,H271910 ,H271989 ,H272077 ,H272161 ,H272258 ,H272357 ,H272453 ,H272877 ,H272967 ,H273074 ,H271667 ,H271748 ,H271823 ,H271911 ,H271990 ,H272079 ,H272164 ,H272261 ,H272358 ,H272455 ,H272878 ,H272969 ,H273078 ,H271670 ,H271749 ,H271824 ,H271912 ,H271991 ,H272080 ,H272165 ,H272262 ,H272361 ,H272457 ,H272879 ,H272970 ,H273079 ,H271671 ,H271750 ,H271826 ,H271913 ,H271992 ,H272082 ,H272166 ,H272263 ,H272363 ,H272459 ,H272880 ,H272972 ,H273081 ,H271672 ,H271751 ,H271827 ,H271914 ,H271996 ,H272083 ,H272167 ,H272264 ,H272364 ,H272461 ,H272881 ,H272974 ,H273085 ,H271673 ,H271752 ,H271828 ,H271915 ,H271997 ,H272084 ,H272170 ,H272265 ,H272366 ,H272463 ,H272882 ,H272975 ,H273087 ,H271674 ,H271753 ,H271829 ,H271916 ,H271998 ,H272087 ,H272171 ,H272266 ,H272367 ,H272465 ,H272883 ,H272976 ,H273090 ,H271675 ,H271754 ,H271830 ,H271917 ,H271999 ,H272088 ,H272175 ,H272268 ,H272368 ,H272467 ,H272884 ,H272977 ,H273091 ,H271676 ,H271756 ,H271832 ,H271919 ,H272002 ,H272090 ,H272176 ,H272269 ,H272369 ,H272468 ,H272886 ,H272979 ,H273094 ,H271677 ,H271757 ,H271834 ,H271920 ,H272004 ,H272091 ,H272177 ,H272270 ,H272371 ,H272471 ,H272887 ,H272980 ,H273095 ,H271679 ,H271758 ,H271836 ,H271922 ,H272005 ,H272092 ,H272181 ,H272272 ,H272373 ,H272472 ,H272888 ,H272983 ,H273097 ,H271680 ,H271759 ,H271837 ,H271923 ,H272006 ,H272093 ,H272182 ,H272273 ,H272374 ,H272475 ,H272891 ,H272984 ,H273098 ,H271682 ,H271761 ,H271839 ,H271924 ,H272007 ,H272094 ,H272183 ,H272274 ,H272375 ,H272477 ,H272892 ,H272988 ,H273099 ,H271683 ,H271764 ,H271840 ,H271925 ,H272010 ,H272095 ,H272185 ,H272276 ,H272376 ,H272478 ,H272894 ,H272989 ,H290001 ,H271684 ,H271765 ,H271841 ,H271927 ,H272011 ,H272096 ,H272186 ,H272278 ,H272378 ,H272482 ,H272895 ,H272991 ,H290003 ,H271685 ,H271766 ,H271842 ,H271928 ,H272012 ,H272097 ,H272189 ,H272279 ,H272379 ,H272483 ,H272896 ,H272992 ,H290004 ,H271686 ,H271768 ,H271843 ,H271929 ,H272013 ,H272098 ,H272190 ,H272280 ,H272382 ,H272484 ,H272897 ,H272994 ,H290014 ,H271687 ,H271769 ,H271844 ,H271930 ,H272015 ,H272099 ,H272191 ,H272281 ,H272383 ,H272485 ,H272898 ,H272995 ,H290026 ,H271688 ,H271770 ,H271846 ,H271932 ,H272017 ,H272100 ,H272192 ,H272282 ,H272384 ,H272489 ,H272900 ,H272997 ,H290030 ,H271689 ,H271771 ,H271847 ,H271933 ,H272018 ,H272101 ,H272193 ,H272284 ,H272385 ,H272490 ,H272901 ,H272998 ,H290031 ,H271692 ,H271772 ,H271848 ,H271934 ,H272019 ,H272102 ,H272194 ,H272285 ,H272386 ,H272493 ,H272902 ,H273000 ,H290032 ,H271695 ,H271774 ,H271849 ,H271936 ,H272020 ,H272103 ,H272196 ,H272286 ,H272387 ,H272495 ,H272903 ,H273001 ,H290033 ,H271696 ,H271775 ,H271850 ,H271937 ,H272021 ,H272104 ,H272198 ,H272287 ,H272389 ,H272496 ,H272904 ,H273002 ,H290034 ,H271697 ,H271776 ,H271851 ,H271938 ,H272022 ,H272106 ,H272199 ,H272288 ,H272390 ,H272800 ,H272906 ,H273005 ,H290104 ,H271698 ,H271777 ,H271852 ,H271939 ,H272024 ,H272107 ,H272200 ,H272289 ,H272391 ,H272802 ,H272907 ,H273007 ,H290105 ,H271699 ,H271778 ,H271854 ,H271940 ,H272025 ,H272108 ,H272201 ,H272292 ,H272392 ,H272807 ,H272913 ,H273008 ,H290109 ,H271700 ,H271779 ,H271855 ,H271943 ,H272026 ,H272109 ,H272205 ,H272294 ,H272393 ,H272808 ,H272915 ,H273010 ,H290110 ,H271701 ,H271781 ,H271857 ,H271944 ,H272027 ,H272110 ,H272206 ,H272295 ,H272395 ,H272809 ,H272916 ,H273012 ,H290111 ,H271702 ,H271782 ,H271859 ,H271945 ,H272028 ,H272112 ,H272207 ,H272296 ,H272396 ,H272810 ,H272917 ,H273013 ,H290113 ,H271703 ,H271784 ,H271861 ,H271946 ,H272030 ,H272113 ,H272208 ,H272297 ,H272398 ,H272812 ,H272918 ,H273014 ,H290114 ,H271704 ,H271786 ,H271863 ,H271947 ,H272032 ,H272114 ,H272210 ,H272298 ,H272399 ,H272813 ,H272919 ,H273017 ,H290116 ,H271705 ,H271787 ,H271864 ,H271948 ,H272034 ,H272116 ,H272211 ,H272300 ,H272400 ,H272814 ,H272920 ,H273018 ,H290118 ,H271706 ,H271788 ,H271865 ,H271949 ,H272036 ,H272117 ,H272212 ,H272303 ,H272402 ,H272815 ,H272921 ,H273019 ,H290121 ,H271707 ,H271789 ,H271867 ,H271950 ,H272038 ,H272119 ,H272213 ,H272304 ,H272403 ,H272817 ,H272923 ,H273020 ,H290122 ,H271708 ,H271790 ,H271868 ,H271952 ,H272039 ,H272121 ,H272215 ,H272305 ,H272404 ,H272818 ,H272924 ,H273021 ,H290123 ,H271709 ,H271791 ,H271869 ,H271953 ,H272040 ,H272122 ,H272217 ,H272308 ,H272406 ,H272819 ,H272925 ,H273022 ,H290125 ,H271710 ,H271792 ,H271871 ,H271955 ,H272041 ,H272123 ,H272218 ,H272312 ,H272408 ,H272821 ,H272927 ,H273023 ,H290128 ,H271715 ,H271793 ,H271873 ,H271956 ,H272046 ,H272124 ,H272221 ,H272314 ,H272409 ,H272823 ,H272928 ,H273024 ,H290130 ,H271716 ,H271794 ,H271874 ,H271957 ,H272047 ,H272125 ,H272222 ,H272315 ,H272411 ,H272829 ,H272929 ,H273025 ,H290132 ,H271717 ,H271795 ,H271876 ,H271958 ,H272048 ,H272126 ,H272224 ,H272316 ,H272414 ,H272830 ,H272930 ,H273028 ,H290135 ,H271718 ,H271796 ,H271878 ,H271959 ,H272051 ,H272127 ,H272227 ,H272317 ,H272415 ,H272831 ,H272931 ,H273033 ,H290137 ,H271719 ,H271798 ,H271880 ,H271960 ,H272053 ,H272128 ,H272228 ,H272319 ,H272417 ,H272833 ,H272934 ,H273034 ,H290138 ,H271722 ,H271799 ,H271882 ,H271962 ,H272054 ,H272130 ,H272229 ,H272320 ,H272419 ,H272836 ,H272935 ,H273037 ,H290139 ,H271723 ,H271800 ,H271883 ,H271963 ,H272055 ,H272131 ,H272230 ,H272322 ,H272420 ,H272838 ,H272937 ,H273038 ,H290141 ,H271725 ,H271803 ,H271884 ,H271965 ,H272056 ,H272132 ,H272232 ,H272323 ,H272424 ,H272839 ,H272939 ,H273043 ,H290145 ,H271726 ,H271804 ,H271885 ,H271967 ,H272057 ,H272133 ,H272233 ,H272330 ,H272429 ,H272840 ,H272940 ,H273044 ,H290151 ,H271727 ,H271805 ,H271886 ,H271968 ,H272058 ,H272135 ,H272234 ,H272331 ,H272430 ,H272843 ,H272942 ,H273045 ,H290152 ,H271728 ,H271806 ,H271887 ,H271969 ,H272059 ,H272139 ,H272238 ,H272332 ,H272431 ,H272844 ,H272943 ,H273046 ,H290154 ,H271731 ,H271807 ,H271888 ,H271970 ,H272060 ,H272140 ,H272241 ,H272334 ,H272433 ,H272845 ,H272944 ,H273047 ,H290155 ,H271732 ,H271808 ,H271889 ,H271971 ,H272061 ,H272141 ,H272242 ,H272335 ,H272435 ,H272850 ,H272947 ,H273050 ,H290156 ,H271733 ,H271809 ,H271891 ,H271977 ,H272063 ,H272142 ,H272244 ,H272337 ,H272436 ,H272851 ,H272948 ,H273051 ,H290157 ,H271734 ,H271810 ,H271892 ,H271978 ,H272065 ,H272144 ,H272245 ,H272338 ,H272437 ,H272852 ,H272949 ,H273054 ,H290158 ,H271735 ,H271812 ,H271894 ,H271979 ,H272066 ,H272145 ,H272246 ,H272340 ,H272439 ,H272853 ,H272950 ,H273058 ,H290159 ,H271736 ,H271813 ,H271897 ,H271980 ,H272067 ,H272146 ,H272247 ,H272342 ,H272441 ,H272855 ,H272952 ,H273059 ,H290160 ,H271737 ,H271814 ,H271898 ,H271981 ,H272068 ,H272147 ,H272248 ,H272344 ,H272442 ,H272861 ,H272954 ,H273060 ,H290161 ,H271738 ,H271815 ,H271899 ,H271982 ,H272070 ,H272148 ,H272249 ,H272347 ,H272443 ,H272863 ,H272955 ,H273061 ,H290162   ,H290164 ,H290280 ,H290357 ,H290531 ,H290165 ,H290281 ,H290359 ,H290532 ,H290166 ,H290283 ,H290360 ,H290534 ,H290168 ,H290284 ,H290363 ,H290535 ,H290173 ,H290285 ,H290364 ,H290536 ,H290175 ,H290286 ,H290365 ,H290537 ,H290176 ,H290288 ,H290366 ,H290539 ,H290181 ,H290289 ,H290367 ,H290542 ,H290182 ,H290290 ,H290368 ,H290543 ,H290185 ,H290291 ,H290369 ,H290544 ,H290187 ,H290292 ,H290370 ,H290545 ,H290189 ,H290293 ,H290373 ,H290546 ,H290191 ,H290296 ,H290374 ,H292832 ,H290193 ,H290297 ,H290377 ,H290194 ,H290299 ,H290378 ,H290195 ,H290301 ,H290380 ,H290196 ,H290302 ,H290382 ,H290197 ,H290305 ,H290383 ,H290198 ,H290306 ,H290384 ,H290203 ,H290307 ,H290385 ,H290206 ,H290309 ,H290387 ,H290209 ,H290310 ,H290388 ,H290210 ,H290311 ,H290389 ,H290211 ,H290312 ,H290390 ,H290212 ,H290314 ,H290393 ,H290213 ,H290315 ,H290394 ,H290214 ,H290316 ,H290395 ,H290215 ,H290318 ,H290396 ,H290216 ,H290319 ,H290398 ,H290217 ,H290320 ,H290404 ,H290219 ,H290322 ,H290406 ,H290220 ,H290323 ,H290408 ,H290223 ,H290324 ,H290409 ,H290225 ,H290325 ,H290410 ,H290226 ,H290327 ,H290411 ,H290227 ,H290328 ,H290412 ,H290229 ,H290329 ,H290413 ,H290231 ,H290330 ,H290415 ,H290235 ,H290331 ,H290416 ,H290236 ,H290332 ,H290417 ,H290237 ,H290333 ,H290424 ,H290239 ,H290334 ,H290425 ,H290240 ,H290335 ,H290426 ,H290242 ,H290336 ,H290427 ,H290244 ,H290337 ,H290500 ,H290246 ,H290338 ,H290502 ,H290247 ,H290339 ,H290506 ,H290250 ,H290340 ,H290507 ,H290255 ,H290342 ,H290513 ,H290257 ,H290343 ,H290514 ,H290258 ,H290344 ,H290515 ,H290259 ,H290345 ,H290516 ,H290260 ,H290346 ,H290518 ,H290261 ,H290347 ,H290521 ,H290264 ,H290348 ,H290522 ,H290265 ,H290349 ,H290523 ,H290266 ,H290350 ,H290524 ,H290268 ,H290351 ,H290525 ,H290269 ,H290353 ,H290526 ,H290271 ,H290354 ,H290527 ,H290275 ,H290355 ,H290528 ,H290279 ,H290356 ,H290529

Radiology Devices

2

No

Worldwide Distribution

Varian High Energy Linear Accelerator, C-Series Clinac, Reference/FSCA Identifier: CP-06611; Models Numbers: 600C, 600CD, 6EX, DBX, 2100C, 2100CD, 2300CD, 21EX, 23EX, DMX, DHX versions 2.x through 6.x; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. || The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Model H48; Serial numbers: H460150 H462049 H462100 H463014 H463044 H463077 H466021 H466036 H466051 H466067 H460907 H462050 H462123 H463015 H463052 H463078 H466022 H466037 H466052 H466068 H461000 H462051 H462124 H463016 H463053 H463080 H466023 H466038 H466053 H466069 H462003 H462055 H462127 H463017 H463054 H463082 H466024 H466039 H466054 H466075 H462004 H462057 H463000 H463018 H463061 H463083 H466025 H466040 H466055 H466082 H462005 H462061 H463001 H463020 H463062 H463093 H466026 H466041 H466056 H466086 H462006 H462072 H463004 H463024 H463064 H463218 H466027 H466043 H466059 H466091 H462011 H462079 H463006 H463038 H463065 H463377 H466028 H466044 H466061 H466092 H462024 H462080 H463008 H463039 H463068 H465519 H466029 H466045 H466062 H468097 H462030 H462082 H463010 H463040 H463070 H466001 H466030 H466046 H466064 H468098 H462045 H462089 H463012 H463042 H463071 H466011 H466031 H466047 H466065   H462048 H462095 H463013 H463043 H463075   H466017 H466032 H466050 H466066.

Radiology Devices

2

No

Worldwide Distribution: Nationwide distribution including the states of AZ, CA, FL, GA, IN, MA, MD, MI, MN, MO, NJ, NY, PA, SC, TN, VA and WV; and the countries of Canada, Austria, Belgium, Brazil, Denmark, Finland, France, Germany, India, Ireland, Italy, Lithuania, Poland, Portugal, Romania, South Africa, South Korea, Spain, Sweden, Switzerland and UK.

Varian Treatment version 6.6.5052. || Varian Medical Systems, || Palo Alto, Ca || Intended to provide accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device form commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.

Catalog Number: 270-2716; Reorder Pack Lot No: 70210702; Expires September 30, 2011. Elution Buffer B: Lot number 270-2718, lot number: GA10430, Exp 2/29/2012.

Hematology and Pathology Devices

2

No

Nationwide distribution: MD, MI, MN, NY, OH, SC, VA and WI.

VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. || Calibrator/Diluent Set. || IVD. || Kit components: || Elution Buffer A, 2 x 2500 mL || Elution Buffer B, 1 x 2100 mL || Wash/Diluent Solution, 1 x 2500 mL || Cartridge Set, 2 Cation exchange Analytical Cartridges, 4 Cation Guard Cartridges; || CD-ROM - || Calibration/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL, deionized water || Whole Blood Primer, 6 x 1 mL || Sample Vials, 2 x 100 || Instruction Manual. || Bio-Rad Laboratories Inc. Hercules, CA 94547 || Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (H LPC).