FDA-Device2013-04-03Class II

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. Th

Vital Images, Inc.
Hazard

Vital Images has found a potential error in measurement generated through the software which affects all versions of 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. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axia

Sold states
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.
Affected count
7649 (Expnaded 5/28/13 to 7654)
Manufactured in
5850 Opus Pkwy Ste 300, Minnetonka, MN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1002-2013

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief