{
  "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": [
    {
      "status": "Ongoing",
      "city": "Lafayette",
      "state": "CO",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92269",
      "recalling_firm": "Medtronic Navigation, Inc.",
      "address_1": "200 Medtronic Drive",
      "address_2": "",
      "postal_code": "80026",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution: PR.  OUS (foreign) distribution: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, Colombia COLOMBIA, C¿TE D'IVOIRE, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, LATVIA, MEXICO, MOLDAVIA, NETHERLANDS, PAKISTAN, POLAND, PORTUGAL, REPUBLIC of KOREA, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES",
      "recall_number": "Z-1666-2023",
      "product_description": "StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems",
      "product_quantity": "556",
      "reason_for_recall": "In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolonged/additional procedure, tissue injury",
      "recall_initiation_date": "20230411",
      "center_classification_date": "20230602",
      "report_date": "20230614",
      "code_info": "Model/UDI-DI/Software Versions: 9735585/00763000253165, 00763000306762 (inside Kits: 00763000299927, 00763000299972), 00763000517267(inside Kits: 00763000517274, 00763000517335)/v3.1.1, 3.1.2, and 3.1.3",
      "more_code_info": ""
    }
  ]
}