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U.S. Department of Health and Human Services

Class 2 Device Recall Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to ve

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 Class 2 Recall
Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to ve
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Date Posted March 27, 2013
Recall Status1 Open
Recall Number Z-1002-2013
Recall Event ID 64461
Premarket Notification
510(K) Numbers
K002519  K062154 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.
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5050410886 5021022792 5080112743 5080114657 5031216581 5030334971 5070120151 5080121203 5050414342 UNK127684 5050910501 5020919640 5070219448 5050413141 5050910390 5050910404 5070934996 5060219224 5060214192 VAU0703006 VAU0703007 5070219421 5070219456 5070222635 5050414679 UNK128481 UNK128485 5050411106 5040913893 5073058666 5070216627 5080118040 5080115168 540660 5090102309 540974 5040230508 5073058631 5090110581 5090104999 5090109214 5060217809 5060220257 5060220265 5020918644 5090110182 CRB1206099 5090110441 5090110441 CRB1206105 CRB1206105 5090110433 CRB1206104 5060220303 5090109354 5080109653 5060219232 5080112832 5080104503 5080119314 5070219464 5080109513 5080102705 5090111081 5080109823 5031218703 5031218711 5070935135 5070935143 5080121998 5090110301 CRB1206102 5080120495 5080120118 5080107324 5080107359 5060214214 5080121955 5080113367 5090107009 CRB1201053 5080101555 5031216271 5080119446 5090111529 5020510637 5070219413 5031216697 5090112207 5030858415 5040229933 5090105685 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5060218503 5060220419 5060220427 5070933760 5090102236 5080101482 7090212968 5060220397 5090107335 5050311217 5080104740 5080106360 5080106379 5080115068 5070933809 5070933817 5080101474 5050913535 5050913608 5080117966 5080112395 5080112549 5080102241 5021126016 5080102942 5080110023 5060215040 5070934228 5050413974 5050414997 5050412129 5090111405 CRB1209123 5080122684 541334 5070220918 5080116390 5060215059 5080102764 UNK116490 UNK116501 N/A 5050311470 5060215598 5050410487 5050910919 5080116439 5080101466 5050410495 5040913141 5050410479 5050411599 5070935062 5080102144 5080116102 5080116110 5090103267 5040913125 5060215571 5080103353 5080109238 5080111607 5020915246 5040913613 5070220969 5060215024 5050310121 UNK147126 5060215032 5090108730 CRU1203032 5070932802 N/A N/A N/A N/A N/A 5040911777 5050411556 5050411564 5080108681 5090103186 5070220896 5080108835 5070221558 5060214036 5080118784 5060218267 5090111316 5070932810 5090109761 5090111138 7090212975 5080121300 5080121319 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5050913942 5050910102 5080108614 5080109440 5080110058 5080112700 5090104921 5090112479 5020916781 5070222538 5080111259 540736 5060211312 5060211320 5050913470 5050913489 5050913497 5070216732 5070222708 1025056 5080110163 5031212470 5031218371 5080106832 5050414571 5050414598 5020712590 5030132767 5090102856 CRU1107016 5021021400 5040229917 5080110422 5080105402 5040225113 5040225180 5060213854 5090111812 CRB1209130 1024944 5050414431 5050414458 5090106657 CRB1112044 5080103817 5050413621 5050413648 5050413656 5040914725 5090103429 CRU1108018 5090104549 5080115157 540654 VESADLCC1210039 5050910927 5050913543 5080119608 540488 1026037 1024089 1024444 5070216783 5090104433 540872 5060220605 5060220613 5090106754 CRB1112045 5030334041 5080104848 5090104417 5060215237 5020713341 5080123311 5070222783 5070222791 5030851720 5030852220 5030859535 5031216948 5040225032 5040914873 5080104082 5080104090 5090111324 CRB1209115 5050415349 5090106517 CRB1112041 5060218384 5060218392 5090111464 CRB1209124 5080121157 540380 VESADLCC1201030 5031217928 5031218320 5050415039 5050415047 5060216497 5070932837 5080103930 5080116889 5090106576 541113 CRB1112042 5060220095 5060220109 5060220117 5060220125 5070932594 5070932608 5070932616 5050413087 5021021907 5050914396 5080103981 5050413419 5030131639 5080118210 5070200143 5090104425 CRU1109021 5080123346 5080109092 5080115211 541056 5060218538 5060220508 5090109109 5090109745 CRB1203078 CRB1203088 5080103493 5080110430 5080111828 5020510750 5060220664 5090109672 1026036 5080117982 541107 1026518 5050910943 5080117990 542000 5030856927 5070222279 5090109737 CRB1203087 5080111682 5080118172 5070931768 1027831 5080114010 5080115877 5090105715 5090108455 CRB1111032 CRB1203065 5040916469 5070219391 5050311276 5050311314 5060212653 5060212661 5060212688 5020712612 5030855718 5080117419 5040224907 5040229895 5090103437 5090112789 5020915084 5080107596 5030851763 5050910441 5030334459 5050414008 5080111895 1027159 5080119616 540405 5060220990 5040228872 5070222252 5070222260 5090109117 CRB1203079 5090102783 CRU1107015 5080104007 5080104015 5050913969 5020511560 5030862277 5030862315 5080102853 5031217693 5080123354 5020713163 5030855904 5080118199 5090103674 CRB1108019 5090108323 CRB1203061 5090104395 5080113480 5060220559 5080102349 5090103631 5080118830 5080108754 5080108746 5080115424 5060215814 505041245 5020511528 5050913977 5070934546 5030542965 5070934333 5090113157 CRB1212160 5060220532 5050914019 5090105022 5030549374 5050311195 5080103302 5050411254 5090111383 CRB1209121 5080104384 5080104333 5040914814 5040229291 5030549536 5050415187 5040917260 5040229089 5030856900 5080115904 5080113901 5060218376 5020917931 5070934473 5040914741 5041211779 5050910978 5070934457 5080115599 5080110929 5070219979 5060220524 5080103280 5080107170 5060218422 5030855440 5050913411 5080102888 5060215725 5080114258 5060218414 UNK115786 UNK115789 5090101973 540555 5070223526 5021022660 5050414180 5090112436 5060214508 5060214516 5090106355 541493 CRB1112035 5050913314 5070934643 5080113677 2100021453 5080123400 CRU1103012 5080119721 5050414229 5090111111 CRB1206110 5080114541 5060218449 5060213730 5040228821 5050910323 5080114932 5060213579 5050413664 5050413672 5090103968 5090103968 CRB1109022 CRB1109022 5021022563 5020511544 5090113521 5060219917 5060220575 5050413273 5050410541 5090108439 5030855920 5080104368 5060219429 5080114118 5080109211 5060218430 5070934074 5060214567 5080108355 5070216686 5030128174 5060214400 5070934937 5080111933 5050910722 5060215792 5070217690 5030859950 5080103973 5030859888 UNK164666 UNK164683 5080115831 5050911877 505091986 5080102357 5080108886 5080107545 5060217361 5020918717 5080111984 5070221620 5070222775 5050911435 5040917031 5060215474 5070216678 5080115432 5040225350 5090111391 CRB1209122 5060220494 5080102624 5070221701 5070931504 5070216775 5070216902 5080120312 5021025732 5080117443 5090113149 CRB1212159 5080116986 542055 5030857478 5080114142 5050414695 5070221647 5090112819 CRB1211147 5080109114 5060217906 5040225393 5060218740 5070934341 5080107200 5060215229 5060214494 5090106134 CRB1112034 5060216489 5070223445 5021022148 5040916736 5080105836 5080105844 5050311306 5080113359 5040225245 5090111251 5090111294 5090111278 5090111308 5080121947 5090111286 5090111243 5060220451 5080114347 5070932330 5070932349 5080109289 5070220861 5070223534 5080111364 5070223488 5080111674 5080113626 5080111356 5080111240 21-26245 5070221612 5060216470 5080111348 5080112247 5080109106 5080101806 5080122846 5090103844 5090103828 5090112940 5090112959 CRB1212151 CRB1212152 5021024426 5041215375 5070933027 5080113219 5080120878 5090108897 5090108900 5090108919 540415 CRB1112036 5090110840 5090110859 5080102322 5080102330 5050413826 5080106352 5080107766 5080107774 5080110376 5070218557 5070218565 5070218573 5080112204 5080110368 5070932098 5070932101 5040912757 5030862463 5090112363 CRB1209139 5020714968 5040916965 5080121025 5070218212 5070932020 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5050412854 5050412862 5090112746 CRB1211144 5050910560 5040919395 5090102775 CRB1107015 5080121351 5050415454 5021022180 5050912857 UNK123193 5070222848 UNK126130 5090112193 CRB1209138 N/A 5050412773 5020511323 97812 5060216020 5040221363 5050914426 5050410762 5050413052 5060218716 5031212578 5073051262 UNK150410 5040918089 5070930494 UNK157534 N/A UNK87859 5080108711 UNK155031 5070934767 5080105240 5080117230 5080117656 540638 5040913435 5070930796 5070223259 5021127128 5060216586 5060220826 5070219480 N/A 5041215219 5080121653 541783 5070124587 5070124625 5080107847 5060217213 5080118865 5070931989 5090104808 UNK55398 5080119713 540900 5020715050 5070933477 5040223994 5060213471 5090113394 542125 5030131299 UNK60285 UNK58815 UNK56841 5080110449 5050310083 UNK56972 5060217183 506014672 5060214656 5060214664 5050913551 5050913578 N/A 5060213005 5080103450 5090112304 5050411823 50504131435 5080117257 5090110263 CRB1206107 5090108560 CRB1203070 5080110945 5060213293 5080106212 5060216926 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5070216791 5070933485 5080109807 5080113596 5040917635 5040515464 5070932152 5070932160 5041211159 5041215901 131046 131047 131048 131049 131050 131051 131052 131053 131054 131055 131056 131057 131058 131059 131060 5070218123 5080109491 5080101857 5080113685 541331 5030852492 5030852492 5080118644 542177 5030856196 5040919778 5090103666 5090103682 CRB1108020 5060212920 5060218465 5060218473 5070221450 5070221469 5070221477 5070221485 5070221507 5080221493 5090112835 5090112843 CRB1211148 5040919433 5040919352 5060216004 5050412749 5030334084 5021127721 5030651594 5031163259 5080112344 540913 5041212287 5090109508 5090109516 CRB1203085 5060212629 5060213498 UNK387576 5040224664 5040224702 5070217992 5060211878 UNK127094 5060220230 5090102252 5090102260 CRB1105014 VESADLCC1209037 5050914353 5060219151 5090102155 5090102171 542732 CRB1104013 5060216047 5090112096 CRB1209137 5030334742 5080109203 5040224834 5070220756 5070934910 VDU0703012 5060216969 5050411882 5041212222 5040912986 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VESADLCC1211040 5090103712 UNK84189 UNK84189 5090109389 CRB1203082 5080105909 5090106452 CRB1112040 5060211738 5080110899 5080102195 5080111569 541304 5030859780 501024825 5070220012 28920A 28920B 5090112533 CRU1211039 5090108676 CRB1203073 UNK143278 5060212939 N/A N/A N/A 5070222317 5040917104 5050910099 UNK149779 5050910234 5090102074 5070930117 5073050940 5031218584 5040917074 5073056825 5060211517 5080101865 5060216292 5060216306 5090106894 5080117893 541823 5040913230 UNK154036 5060217949 5030333975 UNK154876 N/A N/A N/A 127217A 127217B 5073051122 5080112301 5020713880 5070222856 5050912768 UNK61175 5050910293 5050411912 5070222228 5070223046 5041210969 5030547967 5040911858 5070217046 5040919840 5060211231 5060211258 5060216632 5060215326 5060215334 5060216179 UNK132129 UNK145283 5031218665 5070932896 5060216187 5050914388 5060216888 5060216896 5090110026 CRB1203093 5070218425 5070217038 5030335188 5041214603 5041214638 5041215014 5060216527 N/A N/A 5050912482 5080102160 5050411904 UNK138296 5050912733 UNK140537 5050914639 5050914647 5050914655 5050914663 5050914671 5050914698 5050914701 5050914728 5050914744 5050914752 5050914760 5050914779 5050914787 5050914795 5050914809 5080106174 5040223366 5090103887 5030859713 5080116048 UNK130565 5070222929 5050410711 5070220640 UNK144271 5030539514 5080117508 540436 5041215081 5070222902 111867 111876 UNK146188 5050912520 5050914337 5090112495 CRB1211141 5030862293 5070222910 5080121726 5070222864 5080108827 5031212543 5060213196 5060213137 5070218778 5050413575 5050914361 5080104252 5080121645 541618 5030852557 5060213536 5060211673 5090108706 CRU1203031 5060213013 5050415519 5030131078 5040224192 5021021702 5060220680 5080122609 542148 5030859918 5060219712 5050414725 N/A N/A 5070222813 5070217410 5070217526 5050311748 5050311888 5050910668 5050912865 UNK206572 5060212475 5080101741 5080101768 5021126342 5080116471 5090106363 5090106371 5090110093 5090110980 5060220699 UNK149580 50402223552 5070932195 5090111510 CRU1209037 5041212260 5040910851 5070934627 5050912903 5060211029 5040919417 5060211487 5080103167 5030860444 N/A 5040223730 5090106487 CRU1112024 5020510351 5030856153 5050411815 5080102381 5090112312 CRU1107013 UNK111355 111347 5080103019 5090111871 5090111898 CRB1209133 UNK56064 5060220249 5080108495 5080110848 542118 5090111073 71259 71260 71261 CRU1209036 5040221231 5040610017 UNK56907 5050411246 UNK73986 UNK74002 5080113065 542085 5070222333 5080103671 5080110007 5070218166 5090109265 541541 59492 59495 59498 5070932187 5030859014 5060214362 UNK129889 UNK129899 5080120290 541782 5070221388 5070221396 N/A N/A 5021021923 5080111550 149990 5070216996 50702193753 5030545344 5060220354 5060220362 N/A N/A 50300131353 5041210373 N/A N/A N/A 5080103663 5050410606 5060213382 5060213390 5070219200 5070933779 UNK155765 5080116080 5080121211 540719 N/A N/A N/A 5041214646 5030338942 5030338969 5060213463 5070932721 5040514166 5070220799 5060217159 5090107319 CRB1201056 5080113286 542143 5021022741 5020511102 5050311284 5070219707 5070220438 5070220446 5070220454 5070220462 5070220470 5070220489 5070220497 5070220500 5090110999 UNK130224 UNK174993 5031217448 5040224060 5040919859 5050413001 5080103388 5090111626 UNK174992 UNK206013 5090107378 5080101881 5060220885 5080102446 5080120207 5090108714 5070218093 5080104244 5080105313 5080106050 5080107278 5080115912 542007 5070930311 5040513453 5060215954 5060216160 N/A N/A 5041212147 5050415098 5050415101 5050415128 5050415136 5050311853 N/A UNK156283 5080105917 UNK119180 UNK119181 UNK119182 N/A 5070217453 5030130098 5070930710 5080118474 540384 5090110042 CRB1203095 5030539700 5030650482 5031217790 UNK92472 5050415055 5060218163 5030855998 5060218236 5060218244 5041212236 5080110457 541036 5080121432 540781 5050415500 5031217405 5080103132 5070932969 5050414768 5050910579 5080105925 542093 5031218622 5060214427 5050910595 5040913478 5080108436 5030545360 5031217359 5070217593 5080119551 UNK142179 UNK142194 359922 5090109699 5040410018 5040913273 5070217313 5080117524 540704 5070221264 5070221272 5070933523 5070217232 5030334343 5070221965 5050911583 5020917370 5080118652 541343 17722A 17722B 5080103086 5060212726 5060212734 5040223803 5040224257 5041210683 5080120843 5080113227 58742 5070223143 5050913020 5050913039 5090111928 CRB1209135 5030335390 5030335455 5050413346 5070220667 5031163070 5070933361 UNK159847 5050912539 5070222821 5090110972 5080112328 5080113324 540693 5080103574 UNK125282 5060213110 5070217194 5060211576 5041211965 5041215413 5021022490 5050414741 5060217167 5060220877 5070930567 5080106166 131241A 131241B 5070222414 5070933566 UNK93835 UNK154107 58633 58636 5040510152 5080113030 5080118075 540658 541603 5020916811 5050311608 5050410959 5070216708 5080114800 540641 5040226195 5080102209 5070120202 5090111502 CRB1209126 5070218832 5041210942 5050912369 5080116692 5090106770 5090108870 541030 CRB1203090 5060211339 UNK91980 5021125745 UNK91872 5080103620 5090106398 5090106401 5090106428 CRB1112037 UNK71868 5080116064 541428 5090104972 5050414911 5090109486 5090109494 CRB1203084 UNK92393 UNK92396 UNK92399 96453 5070933531 5050912156 5080115343 540322 5050410592 5080104619 N/A 5040223358 5070217143 5050912970 535271 UNK350099 UNK368118 UNK370252 UNK387927 UNK388050 UNK422332 UNK422365 UNK422370 UNK422375 UNK447117 UNK447121 UNK447125 UNK447129 UNK447133 UNK462061 UNK462065 UNK146261 5050411033 5080115076 541902 UNK158709 5080108452 542095 VESADLSV1212004 5080101547 5030132295 N/A UNK158405 5080116498 5080122803 5090102651 5090107408 CRA1107014 CRB1103012 ENP1106001 EOP1106001 VESADLCC1106023 5041215170 N/A 5090105928 CRB1111033 5090106800 CRB1201049 UNK155514 UNK176409 N/A 5040911718 5040911734 5040911750 5040911777 5040911831 5070223402 5070223410 UNK58223 5060212297 5080119810 540601 5070223062 5070930486 5080113707 541289 5040225229 5060216519 UNK57125 5080122374 5090110069 541954 VESADLCC1109025 5080122986 5090109281 542126 5080118687 5050910676 UNK130680 UNK137951 5070934791 5080109785 5030860193 5030860428 5080120193 540376 5060212645 N/A N/A 5070217216 5020510017 5040230036 5040230052 5040230184 5050413788 5050413796 5050413818 5060215318 5060215350 5060215369 5060215407 UNK145177 5020916382 5021126229 5060217027 5060217035 UNK208921 UNK98992 5021127594 5060219046 5040917198 5050910013 UNK26476 5060217132 5050914264 UNK157819 5080101652 5080119632 541064 5050912121 5090106762 CRB1112046 5041211760 5090102511 5050410797 5080105682 UNK156792 5080112255 5060212599 5060212602 5060212610 5090102120 5090102139 5040919875 5040919891 N/A N/A N/A N/A N/A UNK159132 5041214662 5050414172 5020916412 5040229402 5021126482 5090107424 5090109893 5021127039 5070217348 5060220907 5030853650 5050911133 5050911141 5050911168 UNK106949 UNK106950 5050311837 5060217353 UNK139386 5090113165 CRU1212041 5080109998 5050913004 5050913012 5090106746 541890 5070930621 5050914574 5050914582 5070218050 5050912598 N/A N/A N/A 5080106026 5060217914 5090113254 CRU1212043 5060218694 5060218708 UNK138663 5090107297 5070932748 26557 26560 5060214907 5060214923 5040917066 5020510688 5020714003 5080119845 5040223331 5050414393 5070218905 5090111030 5030544690 5050910064 5070223194 5060210839 5080105585 5080106980 5080120886 540506 5030860177 5070218085 5070217402 5021126792 5031214740 5080119705 540324 N/A 5030860363 5080108851 5040225385 5070930346 5030856145 5080105593 541340 5020511919 5020713651 5020713708 5030856110 5040915098 5050411017 5070217631 5080113723 540674 5060213889 5060213897 5073050843 5060213919 5070217011 5080123230 541843 5040915268 5050311594 5030334807 5060216500 76102 76114 76120 UNK140238 5060216837 5020510149 5080102462 5090104379 CRB1109025 5021021044 5080113049 541531 5090112754 CRB1211145 5070221310 5020915440 5020915572 5060215903 5080111232 541821 5030859330 5031212217 UNK129172 5031218096 5090102023 5090102023 UNK150847 5080113790 540651 5020919551 5080121149 5070930370 UNK158241 5040224710 5030132511 N/A N/A N/A 5040915136 5060215997 5060213153 5060213161 TEMP0041886 TEMP0041887 5030131558 5080110015 5050910072 5080107340 541997 UNK157083 5030128611 N/A N/A N/A N/A 5070223232 5090112703 5050415330 5060210758 5060210766 5060210774 5060210782 5070220721 5080122013 540286 UNK206357 5060212238 5060212246 N/A N/A UNK71275 5040224877 5070219669 5050912113 5040220049 5060213188 5060211541 5060219674 5090105723 541672 5060214095 5060215431 UNK109702 UNK109705 5030545409 5060215075 5060216977 5060216985 UNK64668 59174 5060219054 5060217930 5050910617 5070218816 UNK59349 5080103094 5070221345 N/A 5070217607 5030337393 50409919484 5030542434 5080107707 5080106921 5041215138 5070217151 5040910770 5050911508 5060211525 UNK72553 5020714992 5040230419 5080106093 5080111623 UNK121980 UNK121983 5020510491-103450 5020510491-103453 84168 UNK140399 5060211711 UNK141043 5073050770 5040919468 5050412994 5040917120 N/A 5050911516 UNK136739 504125308 5050410789 5073056094 5080109661 5080109793 540799 5041215820 UNK24280 UNK24287 UNK157504 5030859896 5040223420 5050914078 5090106940 CRB1201051 5050914183 5050914302 5060217345 5060217973 5050412919 5080116056 5060219100 5060212572 5060212580 5070217240 5050912377 5090103364 5070120678 5070932764 UNK131956 5090106223 5070932691 UNK144373 UNK144380 5080113375 5060217000 N/A UNK156437 UNK126650 5041212252 5060219623 5060211665 5070217070 5070933612 N/A N/A 5073050649 5080111313 5050410983 5080116501 542009 5070223224 5080109777 UNK72516 5080101636 5090104158 5070218107 5070935097 5040910924 5050913098 5050312108 5060220710 UNK99150 5080119675 541748 UNK99191 5050914329 5070933469 5030549234 5060217191 5090108684 5073050967 5090106703 CRB1201048 5073050983 5040230303 5080120053 541767 5060212769 5060212777 5090104786 5090107564 5090107572 CRB1201059 CRB1203071 5060210022 5040510772 5040913176 UNK156721 5021020641 5050311756 5080113243 5080116129 541414 UNK75374 UNK75379 UNK75383 5080119403 540441 5040913303 5060214257 5060214281 5060214303 5060214311 5070219081 5040910029 5090108331 CRB1201060 5031216891 5020510432 5080113103 5090102716 540644 5041210888 5041210381 5070930834 5030855807 5050911974 5050911982 5050913195 5050913209 5050913217 5050913225 5050913233 5050913276 5050913284 5050913292 5060216101 5070933159 5080103108 5090110654 CRB1206108 5080102993 UNK142388 60707 5060214370 UNK130778 UNK167432 5070930788 5070934694 5080102047 5090110824 5040225253 5060220141 5030855866 5060219003 5080103191 5080104465 5040912625 5041215626 UNK207035 UNK207036 5070219685 5050311918 N/A UNK123064 5050914906 5050911761 5050912644 5060211363 5070217208 5070935100 5080101512 5070200496 5080115408 541324 5041215669 UNK145344 5021127439 5080116544 5080119888 540493 5070221442 5080117648 540413 5080116374 5060215083 5021127152 5040915071 5040915101 5090113440 CRB1212167 5060219690 5030855742 5040913389 5041210608 5080119527 541940 5050311713 5040912846 5030131272 5070217615 5030542264 5080104716 5080106239 5080122927 5090102082 5090102090 540758 5080115696 5040220316 5050912784 5050410657 5050910129 N/A N/A UNK153525 5030114122 5060218139 5050410509 5040225334 5070933590 5070933604 5080119292 541077 508011327 542005 5040919751 5030855734 5090103151 5090103178 CRB1108018 N/A 5050414385 5080116072 5070934899 5090111936 5090111944 CRB1209136 5090113041 CRB1212156 5070223178 UNK156380 5080108479 540839 VESADLCC1209036 5040915586 5060219585 5080121793 541204 5060211681 5050913594 5041211760 5060219658 5060219771 5050912504 5020915432 5070930990 5070931008 5070931016 5070931288 5070931296 5070931318 5041215472 5060220168 5050912954 5050913144 UNK72854 5060217140 5040912811 UNK56054 5030852328 5080105690 5090106959 CRB1201052 5060212491 5080116277 540614 5080103027 5070930168 5070933426 5070930923 5070930931 5070930958 5070930966 5070930974 5070930982 5070931156 5070931164 N/A UNK61337 5060219356 5060219364 5030128085 5050414776 5031217499 5060220761 UNK72422 5070223186 5030859969 5020714127 5070932853 5020916315 5060211460 UNK138249 5060211126 5070930761 5070932756 5031218274 5070217356 5021022725 5021022725 UNK103407 UNK141192 5070930435 5060218007 5080111585 5020914789 5070931970 5050912059 5080106247 5090112932 UNK142604 5041210896 5060214796 5060214818 5060214826 5080112786 5060212947 UNK123232 5021021362 5070218522 5030548394 5090108420 CRB1203064 5060218988 5060219682 UNK143153 5040910797 5070217305 5090109346 541554 UNK144363 5070933353 5060217337 5060210952 5060210960 5060216098 5060217566 5070218158 5090108501 UNK123308 UNK123311 5050311764 5050311845 5060213447 5060214265 5060214273 5090108498 5050910137 5060217558 5060219615 5070217089 5060219097 5080117702 5090104867 CRB1110029 5073050924 5080111690 5080101709 5080101717 5090106789 5090106797 5040224028 5041212201 5070935003 UNK149828 5041212392 5070221892 5070221906 5030539204 UNK158419 5030338047 5050311535 5060213269 5070933035 5080112921 5080101954 5080115084 542224 5040224680 5040224893 5070219162 5070934821 5080108282 542063 UNK153738 5073050665 UNK161114 UNK205359 5070219170 5050913667 5090101981 541971 5041215537 5050410630 5073050819 5090112398 UNK130134 UNK204707 5020917079 5080123214 542046 UNK161240 UNK158446 71854 5060212327 N/A 5060218910 5021021486 5090113238 5030539522 5021025139 5080110317 540808 5060217833 UNK158258 5080103639 5060212637 5030856293 5040223919 5060210391 5050412803 5060211010 5060220702 5070930648 5090102538 5090105901 5073059875 5070220004 5060214842 5080108304 5090112886 5060218198 5060218201 UNK155749 N/A 5060216039 UNK55836 UNK55839 5080117222 5030862455 UNK59953 5041215685 5050311322 5021127144 UNK137996 5030338551 5070930842 5031218061 5070932055 58126 58129 5070218794 5070218808 5090112967 CRB1212153 3070900197 5050312051 5050312078 5070933124 5050910633 5090106711 541686 5021021869 5060219755 5080101725 5060219577 5080113588 5060220923 5060220931 5060220958 5060220966 5030852360 5031218630 5070222384 5041215383 5070120100 5030128557 5080121599 541233 5030132627 5030132627 5060217981 UNK32401 5030856242 UNK54962 307152 5080112859 UNK110771 5050411807 5070930605 5090110883 5060217965 5090106436 CRB1112038 5040223447 5060216152 5070217623 5070217666 5070217674 5080114924 540669 5070222015 5070222074 5070222082 5030545174 5080109467 540662 5070934953 5040510705 5060211061 5060214451 UNK19002 5040223749 5060220869 5070220934 5060220788 5080105437 5070222449 5080110902 540711 5070222430 5070934813 UNK206387 5080103051 UNK138837 5050910021 5070220748 UNK162493 5070220691 5031216816 5080106158 5080121742 UNK128961 UNK128969 UNK128972 5030860134 5070222392 5090112983 CRB1212154 5041210810 5040510810 UNK143102 5040916248 5073050568 5073050771 5070218689 5080115645 541917 5030855785 5080120231 541735 UNK144304 5080110678 540756 5070218360 UNK159980 5021126415 5040917058 5050910056 5060211746 UNK124079 5041215618 5041215618 5080118563 5090113459 5090113467 5090113475 CRB1212168 5040224141 5070934961 UNK130079 5080106948 5080110821 5030539468 5070120831 5080114851 541381 5090105863 5050415276 5050415284 UNK121922 UNK238923 5050912709 5080106255 540869 5080111496 5090102392 542197 5080122994 5060218953 5050910307 5070220772 5073057082 UNK160065 5070218026 UNK157031 5050411947 5060218481 5080117109 540648 5080108312 5080119756 UNK123342 5090109680 5030860304 5090103038 5090105545 UNK158799 5030860282 5050411572 5070219022 5070220268 5090104107 CRB1109023 5060216330 5060220028 5060218082 5050413028 5040911580 5020713899 5070933558 5060217922 5080101644 5080117303 542195 5090108579 5030132325 5080116536 541110 5070218824 N/A N/A 5090110077 541710 N/A 5060211495 5031311426 5080115335 5070934864 5070933582 5070217127 5080119462 542163 5050414792 UNK109308 5070217119 5050912261 5030336818 5030542426 5050912334 5080122722 541519 5040229550 5070930672 5070933493 5060216128 5020915726 5070932950 5050412846 5041215707 5060211134 5050412870 5070222376 5080119993 541131 N/A N/A 5030334270 5080116528 540487 5050410746 5030129294 5070222198 5080118105 5060212521 5090110190 541659 5060211002 N/A 5060211630 5080118571 540714 5040514298 5020915653 5060214435 5040913737 5060211649 5060219763 5080120452 541590 5050912660 5020511579 5020511757 UNK158432 5041215812 5050412927 5070220594 5070933507 5050910692 5041214689 5070932888 UNK126427 N/A N/A 5040225784 UNK156575 5080119926 5070934171 5060216063 5060216144 5040513305 5060215938 5060218902 UNK72557 5070934848 5041215510 5060210979 5050910250 5060219704 5050413044 5031217758 5021022555 5050914914 5080109939 UNK131384 5060219119 5080106085 5080109173 5080113138 5020919470 58391 5060210804 VCU0612003 VDU0612005 5080107995 542099 5050414334 5050910242 5070218077 5070222066 5060213056 UNK57244 5021125974 5021021249 5070222880 5070222945 5080103183 5050911494 5031217774 504091835 5060210340 5080114770 5070933787 5080110651 UNK147938 5070930133 N/A N/A 5070217429 5070222961 5060215547 5080112980 541835 UNK188821 5040917279 5070934902 5060216195 N/A N/A 5030859632 5041212120 5080101504 5050415004 5070218239 5070218247 5050910315 5060217043 5050912180 5041212244 VDU0612001 5070217461 5060213048 5050311357 349528 543841 5060219135 5090103534 50312121709 5020915688 5050910641 5060219143 5080103043 5050415209 5070217550 UNK140043 5090113246 CRU1212042 5070218352 5080102489 5021020943 5080111518 540699 5070934805 5060212319 N/A 5080120932 542204 5060212203 5050912555 5080122943 5060215946 5070934066 5070223216 5070932039 5070932047 5060217590 5040917228 5080108673 5041215774 5090109257 541903 5070930826 5080105232 5080106123 5090109656 CRB1205097 5031216859 5050311799 5090105413 CRB1111031 5070930575 5080106220 5040916973 5080105992 5070930397 5070932632 5080116811 5080116838 5080121386 5080121378 5040223528 N/A 5050912229 5050912490 5080111771 5050412978 5070934708 UNK147686 5041215642 5050411343 5060212416 5060212424 5060212432 5060212440 5060219402 5060219410 5040919786 5090110646 CRB1206106 5070220683 5060218856 5070223038 59063 UNK59057 5020919454 5030132465 5080117737 371035 543843 5031217952 5060211533 5080103566 5090106738 541855 5041213593 5080112298 5080112697 5070218638 5080103825 542115 5021022288 5080115629 5080119861 540407 5040510721 5080103205 N/A 5070930745 5050914280 5050914205 5090108528 CRB1203068 5040225067 5080103841 542012 5050412811 5070933388 5080116145 UNK164410 5070933116 5070933345 5080114789 5090109966 5090110085 5040913346 5031214813 5080109882 5040913397 5080113022 542141 5030131299 5080122617 540267 5050914191 N/A 5020510955 5080115297 N/A 5040228708 5080103078 UNK157224 5090112525 CRU1211040 N/A N/A 5030853278 5040919271 5050310970 5080103175 5080122420 5090102228 541357 5070930141 5040914369 UNK141322 5020511986 5080119918 5070932667 5070933655 5070933663 5070933671 5070933698 5070933701 5070933728 5070933736 5070933744 5080115270 540771 5031218533 5060216829 5080101970 5090102015 5090102031 5020916668 5070930656 5080103035 N/A 5090111596 CRB1209127 5030855750 5030859691 5060213900 5080112778 5021126113 5080103701 5090104182 CRB1109024 UNK21930 5050415470 5090113106 5050412722 5060217825 N/A N/A 5040918291 N/A 5070934775 5050415306 N/A N/A 5050414857 5040514050 UNK154382 5070931520 5040913257 5080118504 541919 5041212570 5050414849 5060213374 5090113211 CRB1212161 UNK59977 UNK59980 5080119411 541645 5031218614 5040223951 5021122837 5040510756 5050914175 5050914221 5050312086 5050312094 5020713406 UNK91788 5080103124 5080117613 UNK61590 5070933450 UNK130171 5050311772 5060214338 5060211444 5090110034 58075 58078 CRB1203094 5070220705 5080117060 541922 5070933922 5040911947 5050413893 5050413907 5060211347 5070222058 5080106131 5080119209 5050412943 5021021168 5050413427 5050414423 5070930443 5031212527 5041211175 5070220713 5080121688 542020 5060217108 5060217116 5060219127 5060219631 UNK153800 5040919255 UNK159124 5080112336 5080107693 50602118635 5060218627 N/A N/A 5080103361 5080106107 5080103523 5050912679 5040913443 5060211568 5060212289 5070217062 UNK110905 5060210987 N/A N/A N/A 5073050754 N/A N/A N/A N/A 5030862285 UNK157075 5050912717 5050414164 5080104325 542111 5080115289 542161 5070222937 5080104937 542199 5070217178 5060214419 5050914345 5030539190 5050910587 UNK72918 5080118660 5070217178 5060219666 UNK71954 UNK71957 5080106077 UNK160249 UNK58639 5030548300 5090109397 CRB1203083 VESADLCC1209038 5080108398 UNK55900 5080111488 5080114428 542087 5080103213 UNK56151 5050911613 5070217186 5080101989 5030862412 5050411025 5040223854 5070934783 5080118598 5090106142 541242 ECP1201001 5040223498 UNK145973 5040510012 5080118679 540678 5070217542 UNK116727 5041215499 5070218581 5070218603 5070218611 5020714607 5020510483 5020920177 5090102066 5070932926 5060220850 5050910269 5070935119 N/A 5070932918 5040913370 5060215989 5050910080 5080119667 541355 5041212074 5050912350 5020510378 5080103140 5080109971 541862 5050912342 5020916552 5070930125 5050411858 5070220357 5040916914 UNK154870 UNK154916 5050911737 5050910781 5050910803 5050910811 5050914566 5060216241 5090104794 CRB1110028 5060212513 5040912420 5080123206 541566 N/A N/A N/A N/A N/A VESADLCC1206034 5070219227 5080118989 541605 5070223240 UNK157727 5040910223 5030131043 5041210012 5060218597 5070220608 5050413478 5050912024 5050912032 5050912040 2511 5070223208 5060216055 5020915815 5080118113 UNK142571 5060211088 5060212971 5020713910 5030218821 5060218805 5060218813 5060218848 5060218899 5080103531 UNK130075 UNK155017 5050413494 5050413508 5050413516 5050413524 5080115637 5080114835 5090109478 542201 5060216373 5060216381 5070222201 5070934988 5060219348 5060220672 5031218495 UNK207135 5040918186 5070222325 5080103116 5080117087 540702 N/A 5090112924 5090112231 5080122447 5080107308 5080107006 5090107181 5090107203 5080117761 5090107157 5090107238 5080112891 5090107173 5080120010 5080116560 5080119365 5090107254 5090107262 5090110255 5070220292 5080106573 5080116552 5080117788 5090102368 5080119969 5090107246 5090107211 5090110212 5090109230 5080119357 5090104964 5090102341 5080121556 5090110964 5090105693 5090105707 5080120266 5070934554 55NFP1S 5050415403 5080102675 5080121548 5050911850 5060218651 5090112827 5090112630 5080111275 5080109505 5080112794 UPDATED: 5070930818 27880 5070222198 5080118105 5090110816
Recalling Firm/
Manufacturer
Vital Images, Inc.
5850 Opus Pkwy Ste 300
Minnetonka, Minnesota 55343-4411
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axia
FDA Determined
Cause 2
DESIGN: Software Design
Action Vital Images sent an "Urgent Field Safety Notice' letter dated February 5, 2013, to all affected customers. The letter identified the probelm the product and the action needed to be taken by the customer. Please immediately inform all potential users of Vitrea of the information contained in this letter. We recommend that all measurements associated with the error described in this letter be verified against results from other technologies. You will be contacted by Vital Images Customer Support or by the customer support department of your distributor to arrange for installation of this patch on your system. We recommend that you implement the patch. If you have an earlier version, Vital Images Customer Support or your distributor will contact you to discuss your options for replacement. Please sign this Notice in the space below to verify that you have received and understood it, and return your signed Notice by email to fieldnotices@vitalimages.com. If you have questions, direct customers of Vital Images should contact Vital Images Customer Support at 1-800-208-3005 or by e-mail to support@vitalimages.com; customers through a distributor of Vital Images products should contact that distributor. Updated 5/28/2013: A second consignee Vital Images, Inc "Urgent Field safety Notice" letter dated March 26, 2013 was sent to consignees on 3/25/13. The follow-up letter was sent via e-mail and mail to 4,616 already-notified consginees, who had received affected versions 6.3.0, 6.2.3, or 6.1.6. The letter described the problem and the affected product being recalled and provided a number of steps to follow which included to retun the Effectiveness Check form.
Quantity in Commerce 7649 (Expnaded 5/28/13 to 7654)
Distribution Worldwide Distribution - All states in continental USA including DC, PR and the countries of ALGERIA, ARGENTINA, ANGOLA, ARMENIA, AUSTRALIA, AUSTRIA, BENGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL BULAGARIA, CAMBODIA, CANADA, CENTRAL AFRICAN REPUBLIC, CHAD, CHILE, CHINA , COLOMBIA, CONGO, CROATIA, CYRPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, JORDAN, KAZAKHASTAN, KOREA, LEBANON, LITHUANIA, MACEDONIA, MALYASIA, MALI, MAURITIUS, MEXICO, MALDOVA, MOSCOW, NYNMAR, NAMBIA, NAMIRGIA, NEPAL, NETHERLANDS, NEW ZEALAND, NIGER, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILLIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, RUSSIAN FEDERATION, SAUDI ARABIA, SENEGAL, SERBIA, SEBIA AND MONROBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOMALIA, SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBERKISTAN, VENEZUELA, VIETNAM and YEMEN.
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 = LLZ and Original Applicant = VITAL IMAGES, INC.
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