{
  "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": "Stockholm",
      "state": "N/A",
      "country": "Sweden",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75731",
      "recalling_firm": "RAYSEARCH LABORATORIES AB",
      "address_1": "Sveavaegen 9",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide Distribution in the states of California, Florida, Illinois, Louisiana, Michigan, New Jersey, Tennessee, Texas, Washington",
      "recall_number": "Z-0721-2017",
      "product_description": "RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System    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": "US: 66 units",
      "reason_for_recall": "Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0.  For treatment plans with a combination of range shifter, large air gap and beams that enter the patient surface at an oblique angle, the dose calculation accuracy may be less than expected.",
      "recall_initiation_date": "20161109",
      "center_classification_date": "20161207",
      "termination_date": "20190611",
      "report_date": "20161214",
      "code_info": "Build numbers: 4.0.2.9\u001d, \u001c4.0.3.4\u001d, \u001c4.5.0.19\u001d, \u001c4.5.1.14\u001d, \u001c4.5.2.7\u001d, \u001c4.7.0.15\u001d, \u001c4.7.1.10\u001d, \u001c4.7.2.5\u001d, \u001c4.7.3.13\u001d, \u001c4.7.4.4\u001d, \u001c4.7.5.4\u001d, \u001d5.0.0.37\u001d, \u001c5.0.1.11\u001d or \u001c5.0.2.35"
    }
  ]
}