{
  "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": "Arden Hills",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62871",
      "recalling_firm": "Galil Medical, Inc.",
      "address_1": "4364 Round Lake Rd W",
      "address_2": "N/A",
      "postal_code": "55112",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US nationwide including the state of  MN and the countries of United Kingdom and Netherlands",
      "recall_number": "Z-2261-2012",
      "product_description": "Visual-ICE¿ Cryoablation System, Model FPRCH 6000    Product Usage: The Galil Medical Visual-ICE\u001d Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures.",
      "product_quantity": "4",
      "reason_for_recall": "Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable.",
      "recall_initiation_date": "20120720",
      "center_classification_date": "20120823",
      "termination_date": "20120913",
      "report_date": "20120829",
      "code_info": "VL0004  VL0014  VL0015  VL0016"
    }
  ]
}