Vitrea Enterprise Suite — Class II medical device recall Z-1002-2013
Terminated recall by Vital Images, Inc., reported 2013-04-03, distributed in DC, GA, GU, PR. Vital Images has found a potential error in measurement generated through the software which affects all versi
| Recall number | Z-1002-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vital Images, Inc., Minnetonka, MN, United States |
| Recall initiated | 2013-02-05 |
| Classified | 2013-03-27 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2015-05-08 |
| Distributed | DC, GA, GU, PR |
| Countries outside the US | AE, AR, AT, AU, BE, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KR, LB, LK, LT, MX, NG, NL, NO, NP, NZ, OM, PA, PE, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Reason classes | software |
| Serial numbers | 1024089, 1024444, 1024944, 1025056, 1026036, 1026037, 1026518, 1027159, 1027804, 1027831, 21-26245, 21-262470, 21-26984, 2100021453, 3090900764, 326827, 357535, 357542, 392039, 424044, 457925, 5020510637, 5020510750, 5020511528, 5020511544 and 475 more |
Product
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.
Reason for recall
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
Machine access
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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.