Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX,…
Medical device recall Z-1181-2013. Published in FDA’s Enforcement Report on May 8, 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 May 8, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 2 states named in where it went
- 1,978 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, 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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
1,978, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 2,000 characters
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…
FDA’s list runs to 19,098 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 -- 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.
The states and territories these words name
- District of Columbia
- Puerto Rico
They leave out Rhode Island and South Dakota.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Mar 15, 2013.
- FDA classified it on Apr 26, 2013.
- FDA’s Enforcement Report published it on May 8, 2013.
- FDA terminated it on Apr 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 19,098 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.