{
  "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": "Plymouth",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63104",
      "recalling_firm": "Vital Images, Inc.",
      "address_1": "5850 Opus Parkway Suite 300",
      "address_2": "N/A",
      "postal_code": "55343-4414",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BULGARIA, CANADA CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, INDIA, INDONESIA, IRAQ, IRELAND, ITALY, IVORY COAST, JAPAN, JORDAN KAZAKHSTAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MALI, MOSCOW, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORTHERN IRELAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SERBIA AND MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TURKEY, UKRAINE, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM,  AND YEMEN",
      "recall_number": "Z-0186-2013",
      "product_description": "Software for Vitrea,  Vitrea fX, and  Vitrea Enterprise Suite (VES):     VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2      VPMC-09346B Vitrea fX   Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2      VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2.    The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional 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, DR, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography. The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate and Auto Gate, allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.",
      "product_quantity": "2088 (1133 USA)",
      "reason_for_recall": "Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite.  This issue affects Version 3.1 of Vitrea fX; Version 5.2 of Vitrea; Versions 6.0, 6.1 and 6.2 of Vitrea and Vitrea fX; and Versions 1.3, 6.0, 6.1 and 6.2 of Vitrea Enterprise Suite; and all updates to those versions.",
      "recall_initiation_date": "20120813",
      "center_classification_date": "20121101",
      "termination_date": "20150325",
      "report_date": "20121107",
      "code_info": "Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2.",
      "more_code_info": ""
    }
  ]
}