{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Atlanta",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75303",
      "recalling_firm": "Elekta, Inc.",
      "address_1": "400 Perimeter Center Ter NE Ste 50",
      "address_2": "N/A",
      "postal_code": "30346-1227",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US to CA, FL, KY, MD, MO, MT, NJ, NC, PA, WA, WI.  Internationally to Algeria. Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, China, Columbia, Croatia, Czech Republic, Ecuador Estonia, France, Germany, India, Iran, Israel, Italy, Japan, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Portugal, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Zimbabwe.",
      "recall_number": "Z-0076-2017",
      "product_description": "Monaco RTP System  The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups",
      "product_quantity": "365",
      "reason_for_recall": "When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.",
      "recall_initiation_date": "20160929",
      "center_classification_date": "20161013",
      "termination_date": "20210716",
      "report_date": "20161019",
      "code_info": "Software Builds 5.10 and 5.20"
    }
  ]
}