{
  "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": [
    {
      "country": "United States",
      "city": "Maryland Heights",
      "address_1": "13723 Riverport Dr Ste 100",
      "reason_for_recall": "It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.",
      "address_2": "",
      "product_quantity": "49 units",
      "code_info": "UDI:  (01)00858164002244(10) 5.50.00   (01)00858164002268(10) 5.51.00",
      "center_classification_date": "20190925",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK",
      "state": "MO",
      "product_description": "Monaco RTP System, 5.50/5.51, radiation treatment planning system    Product Usage:  The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review",
      "report_date": "20191002",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Elekta Inc",
      "recall_number": "Z-2561-2019",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "83692",
      "more_code_info": "",
      "recall_initiation_date": "20190904",
      "postal_code": "63043-4819",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}