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U.S. Department of Health and Human Services

Class 2 Device Recall Vitrea

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 Class 2 Device Recall Vitrea see related information
Date Posted April 26, 2013
Recall Status1 Terminated on April 08, 2015
Recall Number Z-1181-2013
Recall Event ID 64833
510(K)Number K121213  K032748 
Product Classification System, image processing, radiological - Product Code LLZ
Product 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.
Code Information Versions 6.0 and above.
Serial Numbers:

VPE0503066
VPE0911551
VPE0908462
324112


VPE0503082
VPE0707078
VPE0707079




5040227558
5040227590
VPE0503081
VPE0609168
5040227140
VPE0707067
VPE1006732
VPE1011765
VPE0707087
5080113685
VPE0802171
VPE0805209
VPE0805281
VPE0902329
475604
5080121211
357678
5080119381
395647
5090112096
449462
VPE1003630
5090102007


VPE0502007
VPE0602118
VPE0602122
VPE0602117
N/A
N/A
VPE0503073

475635

5090111480
5090111472
5040227329
5031211482


5040919344
VPE0602131
5080117869
5090111960

373409
5090103704
VESADLCC1206033
5090102775
N/A
VPE0503080
5080121653
VPE1211025
5080117230
5030861645
5090104980
470268
5090102848
5080116463
VPE0503068
VPE0707080


VPE0707074
5040227507

5080116269
VPE0503048
5090114366
VPE0710133
5080116382
5080115025
5090110263
VPE0503079
VPE1006755
VPE0503052

5040919425
5090103755
VPE0502024
5040919263
5080119233
VPE0503046
VPE0503059
UPGD1011004
VPE0502001
5080113057
N/A

VPE1202981
5090112835
VPE0702039
5090102252
VESADLCC1209037
5090109508
5090114188
5080108460
5080117117
VPE0503047
5080117486

VPE0710128
VPE0710129
VPE0502002
VPE0710130
VPE0502010
VPE0602145
5090104069
5080115149
5080119934
5080118016
VPE0906417
5090106126
5080111321
VPE0503058
VPE1003661
VPE0502003
VPE1006713

5040227345

VPE0805279


439533
VPE0702040
VPE0503102
VPE1011763


VPE0805246
N/A
VPE0602113
5080120029
VESADLCC1211040
5040227310
5080105909
5090102074
VPE0602112
VPE0503064
5080121645
475539
N/A
VPE0609176
5090112495
VPE0707053
5090108706



N/A
5030852743
361131
5090111510
306459
5080111550
5090109265
VPE0609205
5080120290
VPE0602152
VPE0805276
5031221628
VPE0906416

475819
545925
VPE0602124
5090110042


VPE0710141
VPE0710142
VPE0502014
5080117524
5080118652
VPE0503089
VPE0802199

5080113324
320549
VPE0503050
VPE0802177
5040227035
5030861602

5080114800
VPE0609208


5080113030
5080118075
486565
5080115343
5090102651
5080122803
ENP1106001
361117

VPE0503103
VPE0503051
5090106398
5090106428
5090109486
VPE0503076




VPE0805270
5030852816
N/A
VPE0602140


VPE0707065
5080113790
5080113049
5080111232

VPE0609163
5090105723
VPE0602119
VPE1003624



5080111313
VPE0609170
5080116501
5040226950
VPE0502008
VPE0502029
VPE0602129
VPE0609190
VPE0602123
VPE0502028
VPE0602149
5090106703
VPE0609171
VPE0805288
475818

VPE0702037
5031211520

5080113103
5080117877

357732

5090108420
VPE0502005
518294

5090109346
VPE0503069
5080116277
VPE0602155
518306
VPE0602114
VPE0602135
VEP0609160
VPE0702015
VPE0503065
VPE0710149
5080109467

5090112983
5080121599
VPE0702038



VPE0702027
5030852972
VPE1003612
5080117109
VPE0805216
5090104107
VPE0602111
N/A
5090110190
5080120452
5030861696
5080116528
VPE0602141
5080119993
VPE0702047
5090113246
N/A
VPE0902360

N/A
5080122943
N/A
5080115629

413584
VPE0502023
5090102031

VPE1108820
5080115270

5080119411
5040227086
VPE0707086
5080121688
5030853006
VPE1202992
5090110034
N/A

VPE0805239


5090109397
VESADLCC1209038

5080118989
338704
5080119667
VPE0503104
VPE0805206
5021022946
VPE0602150
VPE0503033
VPE0802161
VPE0609184
VPE0503032
included
5080117087

VPE0503096
VPE0609158
VPE0702032


N/A
475605
475607
VPE0902359
VPE0802178
VPE0805287
VPE0502004
VPE0805285

5090111502

5080123230
VPE0805236
5090113440
5040227051
5040227167
5080116536
VPE0902368
VPE0908467
VPE0609159

VPE0609175
5090113254
5080117265

5031211431
5080122722

5090107300
411472

VPE0702033


5080113707

VPE0609181
5080112980
VPE1011757

5090106827
5090106843
5090111871
VPE0702008
5040919328
included
VPE0702006
VPE0609157
5090109257

5040919360
5090110646
5090108528
5090112525
N/A
VPE0609179
5090110026
5090107319
Recalling Firm/
Manufacturer
Vital Images, Inc.
5850 Opus Pkwy Ste 300
Minnetonka MN 55343-4411
952-487-9500
For Additional Information Contact
952-487-9500
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Labeling design
Action Consignees were sent on 3/15/2013 a VITAL Images, Inc., "Urgent Field Safety Notice" dated March 15, 2013. The letter described the problem and the product involved in the recall. The letter listed the limitations of the product and the steps to take. Consignees were requested to return the Product Recall Effectiveness Check form. Questions should be directed to Vital Images Customer Support at 1-800-208-3005 or via e-mail, support@vitalimages.com.
Quantity in Commerce 1,978
Distribution Worldwide Distribution -- USA, excluding RI and SD and including DC and PR, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELARUS, BOLIVIA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GREECE, GUAM, HONDURAS, HONG KONG, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOSCOW, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SERBIA AND MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, 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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