{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Veenendaal",
      "state": "N/A",
      "country": "Netherlands",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78087",
      "recalling_firm": "Nucletron BV",
      "address_1": "Waardgelder 1",
      "address_2": "POBox 930",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide)  to medical facilities, and to the countries of :  Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland,  Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, United Arab Emirates, and Viet Nam.    There was no military/government distribution.",
      "recall_number": "Z-0050-2018",
      "product_description": "Oncentra Brachy 4.5 radiation therapy software  The firm name on the label is Nucletron B.V.    Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.",
      "product_quantity": "89 customer sites have the affected software",
      "reason_for_recall": "Incorrect source step size may occur in the software plans",
      "recall_initiation_date": "20170810",
      "center_classification_date": "20171026",
      "termination_date": "20201120",
      "report_date": "20171101",
      "code_info": "Versions 4.5, 4.5.1, and 4.5.2."
    }
  ]
}