{
  "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,
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  "results": [
    {
      "status": "Terminated",
      "city": "Stockholm",
      "state": "",
      "country": "Sweden",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71289",
      "recalling_firm": "RAYSEARCH LABORATORIES AB",
      "address_1": "Sveavaegen 9",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide Distribution",
      "recall_number": "Z-1679-2015",
      "product_description": "RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment     Product Usage:  RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.",
      "product_quantity": "Domestic: 539 units",
      "reason_for_recall": "RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.",
      "recall_initiation_date": "20150508",
      "center_classification_date": "20150527",
      "termination_date": "20170411",
      "report_date": "20150603",
      "code_info": "Software Version (Build numbers) 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, or 4.0.3.4",
      "more_code_info": ""
    }
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}