{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "125255",
      "product_res_number": "Z-0845-2014",
      "event_date_initiated": "2014-01-13",
      "event_date_posted": "2014-01-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-02-13",
      "res_event_number": "67319",
      "product_code": "NCX",
      "k_numbers": [
        "K080908"
      ],
      "product_description": "InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V).\n\nProduct Usage:\nThe InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction.\n\n\nK080908",
      "code_info": "Model Numbers: 861470 (120V), 861472 (240V).",
      "firm_fei_number": "3003888399",
      "recalling_firm": "Philips Healthcare",
      "address_1": "6740 Top Gun St",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4114",
      "additional_info_contact": "858-677-6390",
      "reason_for_recall": "Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Philips Healthcare Recall Notice for this proactive performance correction was provided verbally to hospital biomedical engineers.  Philips product support engineering scheduled and conducted the update on customer devices to the most current MCB configuration.",
      "product_quantity": "50",
      "distribution_pattern": "Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherlands, Spain, Sweden, and Switzerland.",
      "openfda": {
        "k_number": [
          "K071358",
          "K063405",
          "K033623",
          "K012512",
          "K141139",
          "K051912",
          "K022366",
          "K070161",
          "K213031",
          "K152946",
          "K080908",
          "K101987",
          "K071008",
          "K220008",
          "K052443",
          "K063829",
          "K080899",
          "K060308",
          "K081936",
          "K223746",
          "K014241",
          "K150046",
          "K030421",
          "K072234",
          "K153162",
          "K153226"
        ],
        "registration_number": [
          "3010617000",
          "2029275",
          "2024311",
          "3029871637"
        ],
        "fei_number": [
          "2024311",
          "3003793491",
          "3029871637",
          "1000306431"
        ],
        "device_name": "System, Hypothermia, Intravenous, Cooling",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5900",
        "device_class": "2"
      }
    }
  ]
}