Reported May 8, 2013 · Terminated
Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced…
Vital Images, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vital Images, Inc. · 5850 Opus Pkwy Ste 300 · Minnetonka, MN · 55343-4411
Is this the product you have?
- Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.
- Lot codes and dates
- Versions 6.0 and above
- Serial NumbersN/A N/A
VPE0503066VPE0911551VPE0908462324112VPE0503082VPE0707078VPE070707950402275585040227590VPE0503081VPE06091685040227140VPE0707067VPE1006732VPE1011765VPE07070875080113685VPE0802171VPE0805209VPE0805281VPE0902329475604508012121135767850801193813956475090112096449462VPE10036305090102007VPE0502007VPE0602118VPE0602122VPE0602117
N/AVPE050307347563550901114805090111472504022732950312114825040919344VPE0602131508011786950901119603734095090103704VESADLCC12060335090102775
N/AVPE05030805080121653VPE121102550801172305030861645509010498047026850901028485080116463VPE0503068VPE0707080VPE070707450402275075080116269VPE05030485090114366VPE0710133508011638250801150255090110263VPE0503079VPE1006755VPE050305250409194255090103755VPE050202450409192635080119233VPE0503046VPE0503059UPGD1011004VPE05020015080113057
N/AVPE12029815090112835VPE07020395090102252VESADLCC12090375090109508509011418850801084605080117117VPE05030475080117486VPE0710128VPE0710129VPE0502002VPE0710130VPE0502010VPE06021455090104069508011514950801199345080118016VPE090641750901061265080111321VPE0503058VPE1003661VPE0502003VPE10067135040227345VPE0805279439533VPE0702040VPE0503102VPE1011763VPE0805246
N/A VPE0609176 5090112495 VPE0707053 5090108706 N/AVPE06021135080120029VESADLCC1211040504022731050801059095090102074VPE0602112VPE05030645080121645475539
N/A5030852743361131509011151030645950801115505090109265VPE06092055080120290VPE0602152VPE08052765031221628VPE0906416475819545925VPE06021245090110042VPE0710141VPE0710142VPE050201450801175245080118652VPE0503089VPE08021995080113324320549VPE0503050VPE0802177504022703550308616025080114800VPE060920850801130305080118075486565508011534350901026515080122803ENP1106001361117VPE0503103VPE0503051509010639850901064285090109486VPE0503076VPE08052705030852816
N/AVPE0602140VPE0707065508011379050801130495080111232VPE06091635090105723VPE0602119VPE10036245080111313VPE060917050801165015040226950VPE0502008VPE0502029VPE0602129VPE0609190VPE0602123VPE0502028VPE06021495090106703VPE0609171VPE0805288475818VPE07020375031211520508011310350801178773577325090108420VPE05020055182945090109346VPE05030695080116277VPE0602155518306VPE0602114VPE0602135VEP0609160VPE0702015VPE0503065VPE0710149508010946750901129835080121599VPE0702038VPE07020275030852972VPE10036125080117109VPE08052165090104107VPE0602111
N/A VPE0902360 N/A 5080122943 N/A5090110190508012045250308616965080116528VPE06021415080119993VPE07020475090113246
N/A5080115629413584VPE05020235090102031VPE1108820508011527050801194115040227086VPE070708650801216885030853006VPE12029925090110034
included 5080117087 VPE0503096 VPE0609158 VPE0702032 N/AVPE08052395090109397VESADLCC120903850801189893387045080119667VPE0503104VPE08052065021022946VPE0602150VPE0503033VPE0802161VPE0609184VPE0503032
included VPE0702006 VPE0609157 5090109257 5040919360 5090110646 5090108528 5090112525 N/A475605475607VPE0902359VPE0802178VPE0805287VPE0502004VPE080528550901115025080123230VPE08052365090113440504022705150402271675080116536VPE0902368VPE0908467VPE0609159VPE060917550901132545080117265503121143150801227225090107300411472VPE07020335080113707VPE06091815080112980VPE1011757509010682750901068435090111871VPE07020085040919328
N/A64 of 64 codes
VPE060917950901100265090107319VPE0602121VPE0802170VPE050309850402274855040919522VPE0805207504022752350308610255080123206VESADLCC120603450801201935080108479VESADLCC1209036VPE0602110VPE071013450801194704758173189985080121793508011967550308609405090113416VPE050308453567850901113835080120053VPE0902345VPE0906400VPE1006730508012079747623950901134595090113475VPE080528050801198105080106980475614VPE0503086509010473550901065335080115408VPE10036254756425090104182VPE0805215VPE06021085080118679VPE0707094358375VPE05020225080113243358016VPE0503099358022341884VPE06091695080116625
N/A VPE1006752 VPE1006747 VPE0609177 5090102155 5090102171 VPE0602142 N/A N/A N/A138 of 138 codes
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
N/AUPGD1009002VPE0702016VPE07020075080109890VPE060920650901064875090112851VPE0609210VPE0609182UPGD1103007BRNPERF2D5090106339VPE0710103VPE090235350801152625080121815VPE1006718VPE1202988VPE06091865090113378509010437950901067545090109087VPE09084585090102309VPE0911576VPE0707064VPE1003657VPE0609188VPE0609187VPE0702004VPE0805210VPE0710118VPE070200350901057155090108455VPE0702011VPE0702012TSV1003001BRNPERF2D5090109222VPE0702009VPE0702010VPE0702002VPE1111913VPE0911582553062VPE0707056VPE08021875090111235VPE07020235080116064
N/A N/AVPE0702025VPE0707085VPE0702026VPE0702028VPE1202964VPE070203150801178935090110077VPE07020415090112533VPE0702043VPE0707061VPE09064205080119683VPE070202150801202314865553468875090113084VPE1003619VPE1006722VPE0702030475673VPE0602154VPE0602127517799VPE0702034VPE07020225080103922
N/A N/AVPE0702048VPE0609202VPE0707055VPE0707054VPE07020463929265080116803VPE07020495080118571VPE0609209VPE0707052VPE0707062VPE0805267VPE0805266VPE07070585080122420VPE0707057VPE0707072VPE09084605090104727VPE0707060VPE1006751VPE0707068VPE1108868VPE0707073VPE0707069VPE0707070VPE0707071VPE0707092VPE0707076VPE07070915080121971VESADLCC1109026VPE0702005VPE12110415080106999VPE0707066VPE0707081VPE0710112VPE0710109VPE0707063487626VPE0710108VPE0710107VPE0805218VPE071012650801070145080114851VPE0710136VPE07070995080105593VPE1011773
N/A243 of 243 codes
VPE0710137VPE0802181VPE07070515080120894VPE0710121VPE0710124VPE0710101VPE07070825090108730VPE0710120VPE07101225080115645VPE0710116VPE0707097VPE0710123VPE0710125VPE0902370VPE0707083VPE0805255VPE07101025090106746VPE0710144VPE07101405090111812VPE07071005090109656VPE0802153VPE07101115090113157VPE08021515080117923VPE0802155VPE0802160VPE0707098VPE1003659VPE0710139VPE0802168VPE0802157VPE0802158VPE0710148VPE0802185VPE0802184VPE0710147VPE0802154VPE07101435080121807VPE0710146VPE0710114VPE0802166VPE08021635090106738VPE0802156VPE1202991VPE0802183VPE0802152VPE0802192VPE0710115VPE0710135VPE0802189VPE0802165
N/A215 of 215 codes
475782VPE0810270VPE0810271VPE081027250801096615090110050VPE0810257VPE0810258340517VPE0902323VPE0902327VPE0902346VPE0810277VPE0810252VPE0902322VPE0902326VPE0810241VPE0902350VPE0902351VPE0902332VPE09023335080123443VPE09023362965885080110678VPE0902344VPE0902356VPE0902366437930VPE0902358VPE0906375VPE09023555080111259508011090250801115185080111291VPE0902352VPE0810280VPE0906398VPE0902369VPE0906399VPE0906402VPE0906404VPE0906407VPE0906406VPE0906405VPE0906403VPE0906395VPE0902340VPE0906414VPE0906413VPE0906410VPE0906409VPE0906408VPE0906418VPE0906411VPE0906401VPE0908446284646VPE1003627
Included50901066495080119004VESADLCC12010285090106134VPE08052655090111111509010987750901066305090109508508012327350801168895090106576VPE11088485090106479509010646050901096485090105405VPE0906373VPE0906374VPE0906376vpe0906378VPE0906386VPE0906388VPE0906390VPE0906393VPE0906397VPE1202990VPE1202975VPE0908456VPE0908465VPE0908478VPE0908479VPE0908489VPE0911539VPE0911540VPE0911541VPE0911545VPE1006716VPE1006717VPE0911548VPE091155450901027325090102694504277VPE0911561VPE0911563508011803250801169865080118598VPE091156450801167815080117648508011669250901067895090106797
Included50901085605090114234VPE12029735040227256508012276550901134915080119241VESADLCC1206035509010988550901086765090109389509011192850901100695080122374VESADLCC11090255090112754VPE11129235090103364360284
551 of 551 codes
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
- Amount recalled
- 1,978
Where it was sold
Why it was recalled
Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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