{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Minnetonka", "state": "MN", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "66659", "recalling_firm": "Vital Images, Inc.", "address_1": "5850 Opus Pkwy Ste 300", "address_2": "N/A", "postal_code": "55343-4411", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Nationwide Distribution - all states in continental USA including DC but not OK or RI. OUS: Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Honduras, Hong Kong, Iceland, Ireland, Italy, Korea, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, r Saudi Arabia, Serbia, Singapore, Slovenia, South Africa,Spain , Sweden, Switzerland, Thailand, Turkey, Ukraine.", "recall_number": "Z-0169-2014", "product_description": "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.", "product_quantity": "598", "reason_for_recall": "Vital Images, Inc. has found an issue in VitreaCore software though internal testing. 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