{
  "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": "Terminated",
      "city": "Louisville",
      "state": "CO",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85243",
      "recalling_firm": "Medtronic Navigation, Inc.",
      "address_1": "826 Coal Creek Cir",
      "address_2": "N/A",
      "postal_code": "80027-9710",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution including US nationwide, Austria, Canada, Italy, Romania, Spain, and United Kingdom.",
      "recall_number": "Z-1995-2020",
      "product_description": "Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License  and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation) procedure.    Neurological stereotaxic Instrument.",
      "product_quantity": "61 customers purchased the specified combination of equipment which may lead to this error.",
      "reason_for_recall": "Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a  fiducial-less  procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).",
      "recall_initiation_date": "20190809",
      "center_classification_date": "20200518",
      "termination_date": "20240402",
      "report_date": "20200527",
      "code_info": "Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination  during a DBS procedure.    Stealthware Station Cranial Software GTIN(s):  00643169878204, 00643169625549    O-Arm Imaging System GTIN(s): 00763000068073, 00763000068080, 00763000068097, 00763000068103, 00763000074050, 00763000074067, 00763000074074, 00763000074081, 00763000074098, 00763000074104, 00763000074111, 00763000074128, 00763000074135, 00763000079000, 00763000079017, 00763000079024, 00763000079031, 00763000079048, 00763000079055, 00763000079062, 00763000079079, 00763000079086, 00763000079093, 00763000079109, 00763000079215, 00763000079246, 00763000079260, 00763000080969, 00763000080976, 00763000080983, 00763000080990, 00763000081003, 00763000081010, 00763000081027, 00763000081034, 00763000081041, 00763000081058, 00763000081065, 00763000081072, 00763000081089, 00763000081096 and 00763000081102.    Nexframe Stereotactic System GTIN(s): DB-2040, 00643169214811; MI-1000, 00643169986763; MI-2000, 00643169986770; NP-1000, 00613994747877."
    }
  ]
}