{
  "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": "2026-08-13",
    "results": {
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  "results": [
    {
      "cfres_id": "35821",
      "product_res_number": "Z-0258-05",
      "event_date_initiated": "2004-11-10",
      "event_date_posted": "2004-11-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-01-12",
      "res_event_number": "30412",
      "product_code": "NCX",
      "k_numbers": [
        "K014241",
        "K030421"
      ],
      "product_description": "Alsius CoolGard 3000 patient temperature regulation system",
      "code_info": "Serial numbers 30000160 and 30000132",
      "firm_fei_number": "3002922896",
      "recalling_firm": "Alsius Corporation",
      "address_1": "15770 Laguna Canyon Rd Ste 150 15770 Laguna Canyon Rd",
      "address_2": "Ste 150",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618-3111",
      "additional_info_contact": "Kenneth Collins\n949-453-0150",
      "reason_for_recall": "Product alarms that there may be a power supply interruption.",
      "root_cause_description": "Other",
      "action": "Firm removed products from use for repair on 11/10/2004.",
      "product_quantity": "2",
      "distribution_pattern": "IL and NC.\n\nSpecifically, Rush University Medical Center, Chicago IL and Duke University medical Center, Durham NC.",
      "openfda": {
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          "3010617000",
          "2029275",
          "3029871637"
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        "fei_number": [
          "3003793491",
          "3029871637",
          "2024311",
          "1000306431"
        ],
        "device_name": "System, Hypothermia, Intravenous, Cooling",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5900",
        "device_class": "2"
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}