Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version…
Medical device recall Z-1002-2013. Published in FDA’s Enforcement Report on Apr 3, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 3, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 7649 (Expnaded 5/28/13 to 7654) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
7649 (Expnaded 5/28/13 to 7654), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 5080109343 5080109769 5080109726 5080123222 5080108401 5080107812 5080107804 5080107790 5080108428 5070933221 5070933248 5070933264 5070933272 5070933256 5080123109 5050411467 5080103442 5080103418 5090110913 5070934023…
Every code shown here, 1,994 characters
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…
FDA’s list runs to 74,977 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- District of Columbia
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 5, 2013.
- FDA classified it on Mar 27, 2013.
- FDA’s Enforcement Report published it on Apr 3, 2013.
- FDA terminated it on May 8, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Vital Images, Inc., of Minnetonka, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 74,977 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.