{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hartland",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77811",
      "recalling_firm": "Merge Healthcare, Inc.",
      "address_1": "900 Walnut Ridge Dr",
      "address_2": "N/A",
      "postal_code": "53029-8347",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide Distribution",
      "recall_number": "Z-3105-2017",
      "product_description": "Merge Unity software, formerly known as DR Systems Unity PACS software.  The firm name on the label is Merge Healthcare, Hartland, WI.  Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems",
      "product_quantity": "98 sites have the potentially affected software",
      "reason_for_recall": "The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.",
      "recall_initiation_date": "20170814",
      "center_classification_date": "20170905",
      "termination_date": "20190508",
      "report_date": "20170913",
      "code_info": "Software versions 10.0, 10.0.1, 10.0.2, 10.0.3, 10.0.4, 10.0.5, 11.0, 11.0.1, 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1, 11.1.1.1, 11.1.1 Patch 2, 11.1.1 Patch 3, 11.1.2, 11.1.2 Patch 1, 11.1.2 Patch 2, 11.1.2 Patch 3, and 11.1.2 Patch 4.    Only customers with one of the above listed software versions AND a license for Mammo Tracking are impacted by this recall."
    }
  ]
}