{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Salt Lake City",
      "state": "UT",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62715",
      "recalling_firm": "GE OEC Medical Systems, Inc",
      "address_1": "384 Wright Brothers Dr",
      "address_2": "N/A",
      "postal_code": "84116-2862",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and the countries of India, Japan, Canada, Switzerland, Italy, United Kingdom, Germany, Austria, Hong Kong, France, and Denmark.",
      "recall_number": "Z-2251-2012",
      "product_description": "OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems.  The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures.  It is intended for use in medical conditions that may benefit from the use of stereotactic surgical technique.  The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.",
      "product_quantity": "768 units",
      "reason_for_recall": "GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment.",
      "recall_initiation_date": "20090622",
      "center_classification_date": "20120828",
      "termination_date": "20120928",
      "report_date": "20120905",
      "code_info": "All serial numbers."
    }
  ]
}