{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Louisville",
      "address_1": "826 Coal Creek Cir",
      "reason_for_recall": "Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.",
      "address_2": "",
      "product_quantity": "27  in total",
      "code_info": "Model Number 9730888. All lot numbers manufactured by Medtronic Navigation are affected.",
      "center_classification_date": "20160802",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.",
      "state": "CO",
      "product_description": "MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.      Product Usage:  The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.",
      "report_date": "20160810",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medtronic Navigation, Inc.",
      "recall_number": "Z-2318-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74715",
      "termination_date": "20161201",
      "more_code_info": "",
      "recall_initiation_date": "20160718",
      "postal_code": "80027-9710",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}