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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description 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 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 including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography.
Recall Number Z-0169-2014
Classification Class II
Code Info Serial Number 540819 5040918941 CRB1209125 540837 541722 CRB1107015 541783 CRB1211144 540638 CRB1110030 CRA1107015 541350 5060218759 3070900036 540864 CRU1302045 540935 345221 CRB1206107 CRB1108021 540970 540249 CRB1211148 CRB1105014 CRB1203085 CRB1212173 541173 3070900134 373677 541633 5080115149 540621 541631 541578 542109 5080111321 5090109540 5080109815 541808 CRU1303050 5080105909 5090102074 5060218090 541618 CRU1303046 CRB1211141 CRU1203031 CRU1209037 542118 5080111550 541541 541782 542085 CRB1305211 CRB1203095 540704 541343 540693 CRB1305217 540641 541603 540322 CRB1103012 CRB1111033 CRB1112037 CRB1203084 541902 5060218686 540651 541531 541821 541997 CRB1302196 541672 542009 CRB1201048 540644 540635 CRB1203064 541554 CRB1302179 5050913152 542224 540614 542046 5060220966 540662 CRB1212154 542197 541233 540648 542195 CRB1109023 542163 541659 541590 540487 541131 CRU1212042 542204 5080122943 5090102031 5080115270 540771 CRB1212161 541645 542020 CRB1203094 CRB1302201 3070900386 CRB1203083 541605 CRB1110028 VESADLSV120900 542087 541355 3070900596 2511 542201 5041210039 5041210179 540702 CRU1303049 CRU1303051 CRU1303047 5050311950 CRB1209126 541843 3070900218 CRB1212167 541110 CRU1212043 540795 541519 CRB1201055 CRB1206108 541289 541835 541922 CRB1201050 CRB1209133 541903 50401210047 CRB1206106 CRB1203068 CRU1211040 CRB1203093 CRB1201056 3070900239 541566 540376 540839 5050911699 5080119470 CSV1303001 542082 CRU1107013 541204 541748 CRB1209121 3070900211 542095 541767 CRA1308021 542126 540552 CRB1212168 540601 5080106980 542005 CRB1109027 CRU1112026 541324 CRB1201049 540678 CRB1302181 541414 542002 541862 3070900421 CRB1305215 540241 540466 542012 CRB1206109 79178 CRB1209139 CRB1302193 541870 5080110910 CRB1209118 541538 540872 540405 CRB1203087 542000 CRB1203067 CRB1203088 CRB1203074 CRB1203079 540415 540886 CRB1302191 542193 CRB1212175 CRB1302180 CRB1212172 CRB1212162 541875 531936 CRB1203072 CRB1306239 CRB1306221 CRU1203030 540914 542175 541956 CRU1112029 541828 CRU1103012 5090105936 542148 542141 5060218082 CRB1201060 102833 540803 541334 5050914604 542732 5070218123 5060214923 CRU1212041 5090107998 542077 VCU0612003 CRB1109026 CRB1201058 540380 CRB1306232 CRB1209122 5080116587 CRB1209129 540431 CRB1302200 CRU1209036 CRB1306226 CRB1302186 CRU1208035 541873 541698 CRB1209120 540934 5080121777 540305 541686 540913 VVC0605010 5080109904 CSV1306002 541383 VDU0703013 CRU1112024 CRB1211149 541001 VSU0910914 541014 CRB1305207 CRB1212163 CRB1109025 CRB1112045 CRB1203076 540974 CRB1203065 CRB1203081 CRB1209114 542063 541428 541823 541710 VDU0706020 VDU0706025 CRU1211039 VCI0706003 540269 541735 VDU0703019 CRB1212157 VCU0612005 5080103922 541028 540714 541357 CRU1109022 540444 CRB1305204 5080106999 3070900120 3070900078 3070900155 525608 541924 541340 3070900260 540467 CRB1306236 CRU1203032 3070900071 541917 CRB1302197 541890 CRB1209130 CRB1205097 CRB1212160 541888 542089 3070900358 541331 541038 541855 543839 3070900407 CRB1305206 541304 3070900449 CRB1203069 CRU1108018 541036 540321 5080103825 5080103698 5080104325 3070900491 542007 541056 5090114226 5080115254 5080103884 5080106263 5080104775 5080106255 542093 CRB1302199 5080107421 540862 542113 5080107979 542119 5090113394 5080108436 3090900680 3090900666 3090900687 3090900673 5080108738 CRB1302184 540349 540799 CRB1205096 5080123443 540756 3090900771 540736 5080110902 540699 5080111291 3090900659 CRB1203086 5080113111 CRB1209138 541171 540674 542146 542157 540540 542143 9111100001 540669 5080114436 540664 540654 540656 540660 542161 CRB1212155 CRU1302044 CRB1306238 540308 541923 540900 CRB1302198 541142 541179 542177 3070900253 541985 410345 CRB1306231 540240 CRB1305214 499222 5090106363 540781 541064 540506 5090102023 540286 CRB1303203 CRB1201051 540441 540758 CRB1203071 540493 541940 541971 CRB1201052 CRB1306220 540267 5090110085 541077 CRB1302182 540484 CRB1112046 540409 CRB1108020 540846 CRB1305212 UNK540719 540428 CRB1209136 540324 540351 CRB1305218 N/A CRU1112028 540739 CRB1112034 CRB1206110 5080119381 CRB1112043 CRU1205034 541401 CRB1112042 3090900764 541480 541467 CRU1107014 CRB1302194 5080118032 542055 543843 541242 5080116781 540413 541030 5090106797 5080121610 CRB1302183 CRB1203070 CRB1212174 CRB1209137 5080122765 CRB1212169 541090 CRB1203092 CRB1203073 CRB1203082 CRB1209135 CRB1302187 541954 CRB1211145 CRU1303048 5090103364 5080121785 CRB1108018 CRB1212156 CRB1211146 540436 541105 5080116021 540555 542061 541107 CRB1212150 CRB1305216 540384 5080118377 541308 541919 541109 540488 5080118547 541129 541153 5090106614 5080121637 541455 541276 5080120045 5080119489 541236 541264 CRB1209116 541430 CRB1209134 540516 540589 541387 541292 CRB1109022 CRB1108019 541413 CRB1211147 CRB1201053 CRU1107015 543307 541443 CRU1109020 CRU1108017 CRU1109019 CRB1112041 CRB1212158 CRU1107016 CRB1305209 CRB1112038 CRB1112039 CRU1109021 CRB1209115 CRU1111023 CRB1201054 540578 CRU1112027 CRB1112044 CRB1112047 5090106622 CRB1203063 CRB1203061 CRB1302192 CRB1209128 541493 CRB1203077 CRB1206113 CRB1201057 CRB1306219 CRB1306227 CRB1209131 CRB1203066 CRB1203075 CRB1305208 5080120959 CRU1203033 CRB1203080 CRB1206101 CRB1302178 CRB1302190 CRB1209117 CRB1211140 CRB1206103 CRB1203089 CRB1209123 CRB1206099 CRB1206102 CRB1206105 CRB1206104 CRB1209132 CRB1209127 CRB1209124 CRB1206112 CRB1212159 CRB1211142 CRB1212151 CRB1305210 VRB1211143 CRB1212165 CRB1212153 CRB1212164 CRU1308052 CRB1212176 CRB1212170 CRB1306237 CRB1212171 CRB1305213 CRB1302195 CRB1302185 CRB1302188 CRB1302189 CRB1305205 CRB1302202 CRB1306225 CRB1306233 CRB1306234 CRB1306228 CRB1306229 CRB1306230
Product Distributed Qty 598
Reason For Recall 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.

Event Detail

Event Id 66659
Product Type Devices
Status Ongoing
Recalling Firm Vital Images, Inc.
City Minnetonka
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution - all states in continental USA including DC but not OK or RI. OUS: Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Honduras, Hong Kong, Iceland, Ireland, Italy, Korea, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, r Saudi Arabia, Serbia, Singapore, Slovenia, South Africa,Spain , Sweden, Switzerland, Thailand, Turkey, Ukraine.
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