Reported Apr 3, 2013 · Terminated
Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except…
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 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.
- Lot codes and dates
- Serial NumberN/A
588 of 588 codes
508010934350801097695080109726508012322250801084015080107812508010780450801077905080108428507093322150709332485070933264507093327250709332565080123109505041146750801034425080103418509011091350709340235080103434507093169550801107755080113081508010297750801032725080113340508012100950801211225080121092508012110650801211145080120827508011163150801117555080116595508011660950801166175080112883508012243950801172145080119764508011977250801197805080123095508012176950801217505090102805507022224450602138705070931709507021664350901132035090103763509010377150901046975090104700509010471950901050305090105049
N/A N/A N/A N/A N/A5050311470506021559850504104875050910919508011643950801014665050410495504091314150504104795050411599507093506250801021445080116102508011611050901032675040913125506021557150801033535080109238508011160750209152465040913613507022096950602150245050310121UNK14712650602150325090108730CRU12030325070932802
N/A N/A1,080 of 1,080 codes
504091177750504115565050411564508010868150901031865070220896508010883550702215585060214036508011878450602182675090111316507093281050901097615090111138709021297550801213005080121319508011779650509135865090102465509010247350709328295090103801506021827950801142665050414040508012305250801230365080117818509011313050901097295080123044508010806150901131225080119691504091687650901095325080114274508012235850702226785070219545508010422850901076105090102198508011909850504104285080118814509010339950801093515090102414504091548950409167875070218514508010940850801188225050415195508011188750901106895080113758
1,006 of 1,006 codes
50702167755090106096509010611850801225365080112263505041195550509134625070222767509010930350702169105060215768508010908450602177875080119160508011260350702227595080110066505091400050801070815080107103508011024450901110495070223585506022000150801171335080105062507022172850801122715080112727505041453950801136505080113669508011080550801085845060219461505091330650602146135060220079508011054650509109515080117567540431506022098250901107785080121297508011917950801050545080105089508010878950801063015090109982509011071950901107355090110727508011825350702234965050414024508011264650702235185080108916
- Serial Number
- Amount recalled
- 7649 (Expnaded 5/28/13 to 7654)
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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