{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Viriat Rhone-Alpes",
      "state": "",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80302",
      "recalling_firm": "Fx Solutions",
      "address_1": "1663 Rue de Majornas",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of: France, Argentina, South Africa, Spain, Israel, Germany, Lebanon, Italy, Chile, Belgium, Greece, Mexico, Poland, Hong Kong, Switzerland",
      "recall_number": "Z-2468-2018",
      "product_description": "Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019    Product Usage:  Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.",
      "product_quantity": "131 units",
      "reason_for_recall": "Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.",
      "recall_initiation_date": "20180604",
      "center_classification_date": "20180717",
      "termination_date": "20190405",
      "report_date": "20180725",
      "code_info": "UDI: 03701037300435  Lot Numbers:    K238, K240, K689R, K1119, K1120, K1121, K1844, L1730, L1737, L1748, L1756, L1764, L1820, M1042  OUS only:  K237, K239",
      "more_code_info": ""
    }
  ]
}