{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "New York",
      "address_1": "500 7th Ave",
      "reason_for_recall": "Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.",
      "address_2": "8th Fl",
      "product_quantity": "10",
      "code_info": "Models/Versions: 1.2.df61abccd836; 1.2.576fd5569198; 1.3.51a5fadf18dd; 1.3.1.b5c53f1fc08d; 1.3.1.694531bfb9c7; 1.3.1.aaffb0cc2485; 1.3.2.6a67eb8088ed; 1.4.a7e352273dd6; 1.6.1.1*; 1.6.2.1*  *Note: versioning scheme was modified to encompass the Build/Commit Number into a fourth digit with the development of version 1.5 (which was never distributed).",
      "center_classification_date": "20200117",
      "distribution_pattern": "Distributed to customers in NY, NJ, and MO.",
      "state": "NY",
      "product_description": "Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.",
      "report_date": "20200129",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Koios Medical, Inc.",
      "recall_number": "Z-0820-2020",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "84615",
      "termination_date": "20200507",
      "more_code_info": "",
      "recall_initiation_date": "20191231",
      "postal_code": "10018-4502",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}