Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 8, 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.
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 performe…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Vital Images, Inc. recalled Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitre… - a moderate-severity action.
Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitre… was recalled by Vital Images, Inc. in May 8, 2013. Reason: Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain per…. Check the official notice for the remedy. Verify recall #Z-1181-2013 with the FDA Devices before acting.
The recall
Vital Images, Inc. issued this moderate-severity FDA Devices recall-Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain per….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- May 8, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1181-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1181-2013) was formally reported on May 8, 2013, with the manufacturer initiating the action on March 15, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Vital Images, Inc. is listed as the recalling firm, operating out of Minnetonka, MN. Federal records list the affected scope as 1,978.
The documented reason for this recall is: 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 acquisit… Distribution data in the federal record shows the product reached: 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, CHIN…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,978
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1181-2013 |
| Date reported | May 8, 2013 |
| Date initiated | March 15, 2013 |
| Recalling firm | Vital Images, Inc. |
| Firm location | Minnetonka, MN |
| Affected scope | 1,978 |
| Distribution | 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,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1181-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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.. Recalled by Vital Images, Inc.. Units affected: 1,978.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2013. Severity: Moderate. Recall number: Z-1181-2013.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1181-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 8, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.