VitreaCore¿ software — Class II medical device recall Z-0169-2014
Terminated recall by Vital Images, Inc., reported 2013-11-13, distributed nationwide. Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for
| Recall number | Z-0169-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vital Images, Inc., Minnetonka, MN, United States |
| Recall initiated | 2013-10-21 |
| Classified | 2013-11-06 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2015-01-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, DE, DK, ES, FI, FR, HK, HN, IE, IS, IT, KR, NL, NO, NZ, PK, PL, PT, QA, RS, SA, SE, SG, SI, TH, TR, UA, ZA |
| Quantity | 598 |
| Reason classes | software |
| Serial numbers | 102833, 2511, 3070900036, 3070900071, 3070900078, 3070900120, 3070900134, 3070900155, 3070900211, 3070900218, 3070900239, 3070900253, 3070900260, 3070900358, 3070900386, 3070900407, 3070900421, 3070900449, 3070900491, 3070900596, 3090900659, 3090900666, 3090900673, 3090900680, 3090900687 and 475 more |
Product
VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital Images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography.
Reason for recall
Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5.
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-0169-2014. 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.