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.

Recall details

Manufacturer

Vital Images, Inc.

Distributor

Worldwide Distribution - All states in continental USA including DC, PR and the countries of ALGERIA, ARGENTINA, ANGOLA, ARMENIA, AUSTRALIA, AUSTRIA, BENGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL BULAGARIA, CAMBODIA, CANADA, CENTRAL AFRICAN REPUBLIC, CHAD, CHILE, CHINA , COLOMBIA, CONGO, CROATIA, CYRPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, JORDAN, KAZAKHASTAN, KOREA, LEBANON, LITHUANIA, MACEDONIA, MALYASIA, MALI, MAURITIUS, MEXICO, MALDOVA, MOSCOW, NYNMAR, NAMBIA, NAMIRGIA, NEPAL, NETHERLANDS, NEW ZEALAND, NIGER, NIGERIA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILLIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, RUSSIAN FEDERATION, SAUDI ARABIA, SENEGAL, SERBIA, SEBIA AND MONROBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOMALIA, SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBERKISTAN, VENEZUELA, VIETNAM and YEMEN.

Lot

Serial Number 5080109343 5080109769 5080109726 5080123222 5080108401 5080107812 5080107804 5080107790 5080108428 5070933221 5070933248 5070933264 5070933272 5070933256 5080123109 5050411467 5080103442 5080103418 5090110913 5070934023 5080103434 5070931695 5080110775 5080113081 5080102977 5080103272 5080113340 5080121009 5080121122 5080121092 5080121106 5080121114 5080120827 5080111631 5080111755 5080116595 5080116609 5080116617 5080112883 5080122439 5080117214 5080119764 5080119772 5080119780 5080123095 5080121769 5080121750 5090102805 5070222244 5060213870 5070931709 5070216643 5090113203 5090103763 5090103771 5090104697 5090104700 5090104719 5090105030 5090105049 5090105057 5090106045 5090106053 5090106568 5090106584 5090106592 5090106606 5090110344 5090110352 5090112800 5060217876 5060217884 5070220144 5070218417 5070931687 5090113181 5090113173 5080103426 5060214044 5080119276 5080119284 5080110783 5080117206 5080119144 5080115483 5080121017 5080117532 5070219472 5080118911 5080108320 5090113548 5080107375 5020918865 5020919055 5080107405 5090113092 5080121963 540349 5050911664 5050911672 5070120134 5070120117 5050410843 5080119454 5080107367 5060218317 5050415063 5050910463 5080122404 5030334610 5080107499 3090900764 5090106460 5090106479 5090109648 457925 5030132252 5080121084 5060219208 5060218228 5060214206 5080116196 5070219405 5080121165 5030859349 5080115572 5080112905 5090111189 CRB1206112 5040916809 5090104298 5020915556 5090111804 5090111847 CRB1209129 5080114444 5080110198 5080108509 5080110465 5080105461 5080105860 5080119039 5080107391 5080108002 5080117559 5080109246 5080107502 5080107383 5080107464 5080107480 5080122781 5030549595 5080121041 540914 5070223372 5030857389 5060214184 5090113084 CRB1212157 5080109610 5080114568 5080112840 5080102519 5080121971 540444 VESADLCC1109026 5080109181 5080110309 5080115556 5080114681 5060219216 5090109567 5090111103 CRB1203086 CRB1206111 5080107758 5040224826 5060219240 5060215296 5060220273 5050410886 5021022792 5080112743 5080114657 5031216581 5030334971 5070120151 5080121203 5050414342 UNK127684 5050910501 5020919640 5070219448 5050413141 5050910390 5050910404 5070934996 5060219224 5060214192 VAU0703006 VAU0703007 5070219421 5070219456 5070222635 5050414679 UNK128481 UNK128485 5050411106 5040913893 5073058666 5070216627 5080118040 5080115168 540660 5090102309 540974 5040230508 5073058631 5090110581 5090104999 5090109214 5060217809 5060220257 5060220265 5020918644 5090110182 CRB1206099 5090110441 5090110441 CRB1206105 CRB1206105 5090110433 CRB1206104 5060220303 5090109354 5080109653 5060219232 5080112832 5080104503 5080119314 5070219464 5080109513 5080102705 5090111081 5080109823 5031218703 5031218711 5070935135 5070935143 5080121998 5090110301 CRB1206102 5080120495 5080120118 5080107324 5080107359 5060214214 5080121955 5080113367 5090107009 CRB1201053 5080101555 5031216271 5080119446 5090111529 5020510637 5070219413 5031216697 5090112207 5030858415 5040229933 5090105685 5050913403 5020920053 50330334971 5021021273 5050311551 5050311578 5050311586 5060218457 5080102268 5080111801 5021020404 5080111283 5060211886 5060213757 5080114304 5050414016 5080121475 5070223461 5080114525 5080105003 5080110473 5050913322 5050410827 5050410835 5020713007 5090106665 CRB1112047 5080117451 5050414547 5070932128 5050910714 5060220346 5090112118 5090112126 5090112134 5090112142 5090112150 5090112169 5090112177 5090112185 5080118180 5080104511 5080114711 5080114738 5080114746 5080114754 5090102929 5090102937 5090102953 5090102945 5090106339 541001 5050413303 5080110252 5090102201 5080119268 540321 5050414237 507093

Risk classification

Class II

Area (FDA)

device

Country

United States