Reported Nov 13, 2013 · Terminated
VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and…
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?
- VitreaCore¿ software
- Versions subject to the limitation6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital Images acquired from
- a variety of imaging devices includingCT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography
- Lot codes and dates
- Serial NumberN/A
433 of 433 codes
5408195040918941CRB1209125540837541722CRB1107015541783CRB1211144540638CRB1110030CRA110701554135050602187593070900036540864CRU1302045540935345221CRB1206107CRB1108021540970540249CRB1211148CRB1105014CRB1203085CRB121217354117330709001343736775416335080115149540621541631541578542109508011132150901095405080109815541808CRU1303050508010590950901020745060218090541618CRU1303046CRB1211141CRU1203031CRU12090375421185080111550541541541782542085CRB1305211CRB1203095540704541343540693CRB1305217540641
160 of 160 codes
CRU1112028540739CRB1112034CRB12061105080119381CRB1112043CRU1205034541401CRB11120423090900764541480541467CRU1107014CRB13021945080118032542055543843541242508011678154041354103050901067975080121610CRB1302183CRB1203070CRB1212174CRB12091375080122765CRB1212169541090CRB1203092CRB1203073CRB1203082CRB1209135CRB1302187541954CRB1211145CRU130304850901033645080121785CRB1108018CRB1212156CRB12111465404365411055080116021540555542061541107CRB1212150CRB130521654038450801183775413085419195411095404885080118547541129541153
- Serial Number
- Amount recalled
- 598
Where it was sold
Why it was recalled
Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5.
This product could cause temporary or reversible health problems — stop using it.
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