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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1181-2013

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.

Publicado el 8 de mayo de 2013 · Inicio del retiro: 15 de marzo de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Vital Images, Inc.
Distribuidor
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.
Lote
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
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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