Vitrea¿ CT Brain Perfusion made available in various configurations… — Class II medical device recall Z-1181-2013
Terminated recall by Vital Images, Inc., reported 2013-05-08, distributed in DC, GA, GU, PR, RI, SD. Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perf
| Recall number | Z-1181-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vital Images, Inc., Minnetonka, MN, United States |
| Recall initiated | 2013-03-15 |
| Classified | 2013-04-26 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2015-04-08 |
| Distributed | DC, GA, GU, PR, RI, SD |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, GR, HK, HN, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KR, KW, LB, LK, LT, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 1,978 |
| Serial numbers | 306459, 320549, 324112, 338704, 357678, 357732, 361117, 361131, 373409, 395647, 413584, 439533, 449462, 470268, 475539, 475604, 475635, 475818, 475819, 486565, 5021022946, 5030852743, 5030852816, 5030852972, 5030853006 and 243 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1181-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.