{
  "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": "The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.",
      "address_2": "",
      "product_quantity": "60 instruments",
      "code_info": "Lot numbers 17022451,17011750, 16120349, 16082989, 16081888, 16071987, 16062713, and 16060712",
      "center_classification_date": "20170821",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) and Internationally to Canada.",
      "state": "CO",
      "product_description": "Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx.  The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.  The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it",
      "report_date": "20170830",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medtronic Navigation, Inc.",
      "recall_number": "Z-3054-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "77739",
      "termination_date": "20180803",
      "more_code_info": "",
      "recall_initiation_date": "20170629",
      "postal_code": "80027-9710",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}