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U.S. Department of Health and Human Services

Class 2 Device Recall Exact Couch with Exact Couch Top

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  Class 2 Device Recall Exact Couch with Exact Couch Top see related information
Date Initiated by Firm August 11, 2008
Date Posted October 20, 2008
Recall Status1 Terminated 3 on November 27, 2010
Recall Number Z-0117-2009
Recall Event ID 49399
510(K)Number K904364  K033339  
Product Classification Linear Accelerator - Product Code IYE
Product Exact Couch with Exact Couch Top, a component of the C-Series Clinacs, Acuity and Ximatron treatment systems. Model numbers H14, H18, H27, H72, H77. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.
Code Information Serial numbers: H140001 H140044 H140086 H180113 H180439 H180505 H180544 H180586 H180631 H140002 H140045 H140087 H180114 H180446 H180506 H180545 H180587 H180632 H140003 H140046 H140088 H180115 H180448 H180507 H180546 H180588 H180633 H140004 H140047 H140089 H180130 H180449 H180508 H180547 H180590 H180634 H140005 H140048 H140090 H180132 H180452 H180509 H180548 H180591 H180635 H140006 H140049 H140091 H180136 H180468 H180510 H180549 H180592 H180636 H140007 H140050 H140092 H180138 H180469 H180511 H180550 H180593 H180637 H140008 H140051 H140093 H180141 H180470 H180512 H180551 H180594 H180638 H140009 H140052 H140094 H180147 H180471 H180513 H180552 H180595 H180639 H140010 H140053 H140095 H180157 H180472 H180514 H180553 H180596 H180640 H140011 H140054 H140096 H180167 H180473 H180515 H180554 H180597 H180641 H140012 H140055 H140097 H180170 H180474 H180517 H180555 H180598 H180642 H140014 H140056 H140098 H180172 H180475 H180518 H180556 H180599 H180643 H140015 H140057 H140099 H180173 H180476 H180519 H180557 H180600 H180644 H140016 H140058 H140100 H180183 H180477 H180520 H180558 H180601 H180645 H140017 H140059 H140101 H180186 H180478 H180521 H180559 H180602 H180646 H140018 H140060 H140102 H180197 H180479 H180522 H180560 H180603 H180647 H140019 H140061 H140103 H180204 H180480 H180522 H180561 H180604 H180648 H140020 H140062 H140105 H180207 H180482 H180523 H180561 H180605 H180649 H140021 H140063 H140106 H180208 H180483 H180524 H180562 H180606 H180650 H140022 H140064 H140107 H180210 H180484 H180525 H180563 H180607 H180651 H140023 H140065 H140108 H180222 H180485 H180526 H180564 H180610 H180652 H140024 H140066 H140109 H180231 H180486 H180527 H180565 H180611 H180653 H140025 H140067 H140110 H180242 H180487 H180528 H180566 H180612 H180654 H140026 H140068 H140111 H180248 H180488 H180529 H180568 H180613 H180655 H140027 H140069 H140112 H180256 H180489 H180529 H180569 H180614 H180656 H140028 H140070 H140113 H180260 H180490 H180530 H180570 H180615 H180657 H140029 H140071 H140114 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H272864 H272223 H272265 H272307 H272349 H272391 H272433 H272476 H272822 H272865 H272224 H272266 H272308 H272350 H272392 H272434 H272477 H272823 H272866 H272225 H272267 H272309 H272351 H272393 H272435 H272478 H272824 H272867 H272226 H272268 H272310 H272352 H272394 H272436 H272479 H272825 H272868 H272227 H272269 H272311 H272353 H272395 H272437 H272480 H272826 H272869 H272228 H272270 H272312 H272354 H272396 H272438 H272482 H272827 H272870 H272229 H272271 H272313 H272355 H272397 H272439 H272483 H272828 H272871 H272230 H272272 H272314 H272356 H272398 H272440 H272484 H272829 H272872 H272231 H272273 H272315 H272357 H272399 H272441 H272485 H272830 H272873 H272232 H272274 H272316 H272358 H272400 H272442 H272488 H272831 H272875 H272233 H272275 H272317 H272359 H272401 H272443 H272489 H272833 H272876 H272234 H272276 H272318 H272360 H272402 H272444 H272490 H272834 H272877 H272235 H272277 H272319 H272361 H272403 H272445 H272491 H272835 H272878 H272236 H272278 H272320 H272362 H272404 H272446 H272492 H272836 H272879 H272237 H272279 H272321 H272363 H272405 H272447 H272493 H272837 H272880 H272238 H272280 H272322 H272364 H272406 H272448 H272494 H272838 H272881 H272239 H272281 H272323 H272365 H272407 H272449 H272495 H272839 H272882 H272240 H272282 H272324 H272366 H272408 H272450 H272496 H272840 H272883 H272241 H272283 H272325 H272367 H272409 H272451 H272497 H272841 H272884 H272242 H272284 H272326 H272368 H272410 H272452 H272498 H272842 H272885 H272243 H272285 H272327 H272369 H272411 H272453 H272500 H272843 H272886 H272244 H272286 H272328 H272370 H272412 H272454 H272800 H272844 H272887 H272245 H272287 H272329 H272371 H272413 H272455 H272801 H272845 H272888 H272246 H272288 H272330 H272372 H272414 H272456 H272802 H272846 H272889 H272247 H272289 H272331 H272373 H272415 H272457 H272803 H272847 H272890 H272248 H272290 H272332 H272374 H272416 H272458 H272804 H272848 H272891 H272249 H272291 H272333 H272375 H272417 H272459 H272805 H272849 H272892 H272250 H272292 H272334 H272376 H272418 H272460 H272806 H272850 H272893 H272251 H272293 H272335 H272377 H272419 H272461 H272807 H272851 H272894 H272252 H272294 H272336 H272378 H272420 H272462 H272808 H272852 H272895 H272253 H272295 H272337 H272379 H272421 H272463 H272809 H272853 H272896     H272897 H272939 H290142 H290195 H290234 H290274 H290316 H290358 H290399 H272898 H272940 H290145 H290196 H290235 H290275 H290317 H290359 H290400 H272899 H272941 H290147 H290197 H290236 H290276 H290318 H290360 H290401 H272900 H272942 H290148 H290198 H290237 H290277 H290319 H290361 H290402 H272901 H272943 H290153 H290199 H290238 H290278 H290320 H290362 H290403 H272902 H272944 H290154 H290200 H290239 H290279 H290321 H290363 H290404 H272903 H272946 H290155 H290201 H290240 H290280 H290322 H290364 H290405 H272904 H272947 H290156 H290202 H290241 H290281 H290323 H290365 H290406 H272905 H272948 H290157 H290203 H290242 H290282 H290324 H290366 H290407 H272906 H272949 H290161 H290203 H290243 H290283 H290325 H290367 H290408 H272907 H272950 H290163 H290204 H290244 H290284 H290326 H290368 H290409 H272908 H272951 H290164 H290204 H290245 H290285 H290327 H290369 H290410 H272909 H272952 H290165 H290205 H290245 H290286 H290328 H290370 H290411 H272910 H272953 H290165 H290206 H290246 H290287 H290329 H290371 H290412 H272911 H290002 H290166 H290207 H290247 H290288 H290330 H290372 H290413 H272912 H290006 H290167 H290208 H290248 H290289 H290331 H290372 H290414 H272913 H290008 H290168 H290209 H290249 H290290 H290332 H290373 H290415 H272914 H290010 H290169 H290210 H290250 H290291 H290333 H290374 H290416 H272915 H290012 H290170 H290211 H290251 H290292 H290334 H290375 H290417 H272916 H290017 H290171 H290212 H290251 H290293 H290335 H290376 H290422 H272917 H290018 H290172 H290213 H290252 H290294 H290336 H290377 H290423 H272918 H290024 H290173 H290214 H290253 H290295 H290337 H290378 H290424 H272919 H290026 H290175 H290215 H290254 H290296 H290338 H290379 H290425 H272920 H290030 H290176 H290216 H290255 H290297 H290339 H290380 H290426 H272921 H290031 H290177 H290217 H290256 H290298 H290340 H290381 H290427 H272922 H290032 H290178 H290218 H290257 H290299 H290341 H290382 H290500 H272923 H290033 H290179 H290219 H290258 H290300 H290342 H290383 H290501 H272924 H290034 H290180 H290220 H290259 H290301 H290343 H290384 H290502 H272925 H290104 H290181 H290220 H290260 H290302 H290344 H290385 H290503 H272926 H290106 H290182 H290221 H290261 H290303 H290345 H290386 H290504 H272927 H290108 H290183 H290222 H290262 H290304 H290346 H290386 H290505 H272928 H290109 H290185 H290223 H290263 H290305 H290347 H290387 H290506 H272929 H290110 H290186 H290224 H290264 H290306 H290348 H290388 H290507 H272930 H290114 H290187 H290225 H290265 H290307 H290349 H290389 H290508 H272931 H290115 H290188 H290226 H290266 H290308 H290350 H290390 H290509 H272932 H290117 H290189 H290227 H290267 H290309 H290351 H290391 H290510 H272933 H290120 H290190 H290228 H290268 H290310 H290352 H290392 H290511 H272934 H290122 H290191 H290229 H290269 H290311 H290353 H290393 H290512 H272935 H290123 H290192 H290230 H290270 H290312 H290354 H290394 H290513 H272936 H290128 H290193 H290231 H290271 H290313 H290355 H290395 H290514 H272937 H290132 H290194 H290232 H290272 H290314 H290356 H290396 H290515 H272938 H290135 H290194 H290233 H290273 H290315 H290357 H290397 H290516     H290517 H290561 H720425 H720633 H720738 H720784 H720828 H720872 H720916 H290518 H290600 H720429 H720638 H720739 H720785 H720829 H720873 H720918 H290519 H720040 H720432 H720643 H720741 H720786 H720830 H720874 H720919 H290520 H720060 H720434 H720647 H720742 H720787 H720831 H720875 H720920 H290521 H720070 H720435 H720650 H720743 H720788 H720832 H720876 H720921 H290522 H720076 H720445 H720651 H720744 H720789 H720833 H720877 H720922 H290523 H720102 H720453 H720653 H720745 H720790 H720834 H720878 H720923 H290524 H720109 H720455 H720654 H720746 H720791 H720835 H720879 H720924 H290525 H720113 H720461 H720665 H720747 H720792 H720836 H720880 H720925 H290526 H720114 H720463 H720667 H720748 H720793 H720838 H720881 H720926 H290527 H720121 H720473 H720668 H720749 H720794 H720839 H720882 H720927 H290528 H720130 H720474 H720679 H720750 H720795 H720840 H720883 H720928 H290529 H720173 H720475 H720690 H720751 H720796 H720841 H720884 H720929 H290530 H720182 H720481 H720692 H720752 H720797 H720842 H720885 H720930 H290531 H720213 H720492 H720709 H720753 H720798 H720843 H720886 H720931 H290532 H720233 H720499 H720711 H720754 H720799 H720843 H720888 H720932 H290533 H720247 H720500 H720712 H720755 H720801 H720844 H720889 H720933 H290534 H720248 H720502 H720714 H720756 H720802 H720845 H720890 H720934 H290535 H720262 H720513 H720715 H720757 H720803 H720846 H720891 H720935 H290536 H720269 H720514 H720716 H720759 H720804 H720847 H720892 H720936 H290537 H720276 H720515 H720717 H720760 H720805 H720848 H720893 H720937 H290538 H720278 H720521 H720718 H720761 H720806 H720850 H720894 H720938 H290539 H720282 H720535 H720719 H720762 H720807 H720851 H720895 H720939 H290540 H720291 H720536 h720719 H720763 H720808 H720852 H720896 H720940 H290541 H720294 H720541 H720720 H720765 H720809 H720854 H720897 H720941 H290542 H720297 H720542 H720721 H720766 H720810 H720855 H720898 H720942 H290543 H720308 H720548 H720722 H720767 H720811 H720856 H720899 H720943 H290544 H720309 H720551 H720723 H720768 H720812 H720857 H720900 H720944 H290545 H720319 H720556 H720724 H720769 H720813 H720858 H720901 H720945 H290546 H720347 H720559 H720724 H720770 H720814 H720859 H720902 H720946 H290547 H720349 H720562 H720725 H720772 H720815 H720860 H720903 H720947 H290548 H720350 H720566 H720726 H720773 H720816 H720861 H720904 H720948 H290549 H720356 H720568 H720727 H720774 H720817 H720862 H720905 H720949 H290550 H720361 H720571 H720727 H720775 H720818 H720863 H720906 H720950 H290551 H720364 H720578 H720728 H720776 H720819 H720864 H720907 H720951 H290552 H720367 H720581 H720729 H720777 H720820 H720865 H720908 H720952 H290553 H720377 H720596 H720730 H720778 H720822 H720866 H720909 H720953 H290554 H720379 H720602 H720732 H720779 H720823 H720867 H720910 H720954 H290555 H720387 H720613 H720733 H720780 H720824 H720868 H720911 H720955 H290556 H720388 H720617 H720734 H720781 H720825 H720869 H720913 H720956 H290558 H720408 H720621 H720736 H720782 H720826 H720870 H720914 H720957 H290559 H720418 H720632 H720737 H720783 H720827 H720871 H720915 H720958     H720959 H721002 H721045 H770042 H770086 H770129 H770171 H720960 H721003 H721046 H770043 H770087 H770130 H770172 H720961 H721004 H721047 H770045 H770088 H770131 H770173 H720962 H721005 H721048 H770046 H770089 H770132 H770174 H720963 H721006 H770002 H770047 H770090 H770133 H770175 H720964 H721007 H770004 H770048 H770091 H770134 H770176 H720965 H721008 H770005 H770049 H770092 H770135 H770177 H720966 H721009 H770006 H770051 H770093 H770136 H770178 H720967 H721010 H770007 H770052 H770094 H770137 H770179 H720968 H721011 H770009 H770053 H770095 H770138 H770180 H720969 H721012 H770010 H770054 H770096 H770139 H770181 H720970 H721013 H770011 H770055 H770097 H770140 H770182 H720971 H721014 H770012 H770056 H770098 H770141 H770183 H720973 H721015 H770013 H770057 H770099 H770142 H770184 H720974 H721016 H770014 H770058 H770100 H770143 H770185 H720975 H721017 H770015 H770059 H770101 H770144 H770186 H720976 H721018 H770016 H770060 H770102 H770145 H770187 H720977 H721019 H770017 H770061 H770103 H770146 H770188 H720978 H721020 H770018 H770062 H770104 H770147 H770189 H720979 H721022 H770019 H770063 H770105 H770148 H770190 H720980 H721023 H770020 H770064 H770106 H770149  H720981 H721024 H770021 H770065 H770107 H770150  H720982 H721025 H770022 H770066 H770108 H770151  H720983 H721026 H770023 H770067 H770109 H770152  H720984 H721027 H770024 H770068 H770110 H770153  H720985 H721028 H770025 H770069 H770112 H770154  H720986 H721029 H770026 H770070 H770113 H770155  H720987 H721030 H770027 H770071 H770114 H770156  H720988 H721031 H770028 H770072 H770115 H770157  H720989 H721032 H770029 H770073 H770116 H770158  H720990 H721033 H770030 H770074 H770117 H770159  H720991 H721034 H770031 H770075 H770118 H770160  H720992 H721035 H770032 H770076 H770119 H770161  H720993 H721036 H770033 H770077 H770120 H770162  H720994 H721037 H770034 H770078 H770121 H770163  H720995 H721037 H770035 H770079 H770122 H770164  H720996 H721038 H770036 H770080 H770123 H770165  H720997 H721040 H770037 H770081 H770124 H770166  H720998 H721041 H770038 H770082 H770125 H770167  H720999 H721042 H770039 H770083 H770126 H770168  H721000 H721043 H770040 H770084 H770127 H770169  H721001 H721044 H770041 H770085 H770128 and H770170  
Recalling Firm/
Varian Medical Systems Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact
Manufacturer Reason
for Recall
During couch movement, a patient's fingers may get pinched at certain points which could result in broken, disengaged or pinched fingers.
FDA Determined
Cause 2
Device Design
Action Recall initiated on 08/11/2008. Notification will be sent to Varian Sales, Marketing and Service organizations as well as to all affected users. Contact Varian Medical Systems Oncology Systems, at 1-650-424-5731 for assistance.
Quantity in Commerce 3296 units
Distribution Worldwide including to the US and to Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, The Netherlands, United Kingdom, Algeria, Australia, Bahrain, Bangladesh, Belorussia, Bolivia, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, Guadeloupe, Hong Kong, India, Indonesia, Iran, Israel, Jamaica, Japan, Kazakhstan, Lebanon, Macau, Macedonia, Malaysia, Martinique, Mexico, Morocco, Nepal, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Russian Fed., Saudi Arabia, Serbia, Montenegro, Singapore, South Africa, South Korea, Sudan, Syria, Taiwan, R.O.C., Thailand, Turkey, U.A.E, Ukraine, Uruguay, Venezuela, and Vietnam.
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 ASSOC., INC.
510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.