{
  "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": "Cleveland",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69793",
      "recalling_firm": "Philips Medical Systems (Cleveland) Inc",
      "address_1": "595 Miner Rd",
      "address_2": "N/A",
      "postal_code": "44143-2131",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US Distribution in states of: FL, NC, and VT; and the countries of Argentina, Austria, Belgium, Canada, Denmark, France, India, Italy, Japan, Netherlands, United Kingdom, and Vietnam.",
      "recall_number": "Z-0473-2015",
      "product_description": "IntelliSpace Portal DX/HX/EX model number: 881001  IntelliSpace Portal DX/HX/EX Upgrade model number: 881011  IntelliSpace Portal DX/HX/EX Demo model number: 881012  IntelliSpace Portal IX model number; 881030  System, x-ray, tomography, computed",
      "product_quantity": "32",
      "reason_for_recall": "Software defect.  In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (THV) to be implanted .",
      "recall_initiation_date": "20141109",
      "center_classification_date": "20141126",
      "termination_date": "20150914",
      "report_date": "20141203",
      "code_info": "IntelliSpace Portal DX/HX/EX: 96027,96029,96025,96030,96031,85479,79935,  98087,85175,96024,106013,450003, 950002, 950003,35009,35030,870056, 550012, 85081, 97069, 45001985333, 35036, and 85382.  IntelliSpace Portal DX/HX/EX Upgrade: 950100, 55003, and 81178.  IntelliSpace Portal DX/HX/EX Demo: 85451 and 87290.  IntelliSpace Portal IX: 50306, 40219, and 40368.    IntelliSpace Portal DX/HX/EX model number: 881001  IntelliSpace Portal DX/HX/EX Upgrade model number: 881011  IntelliSpace Portal DX/HX/EX Demo model number: 881012  IntelliSpace Portal IX model number; 881030",
      "more_code_info": ""
    }
  ]
}