{
  "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": [
    {
      "status": "Terminated",
      "city": "Stockholm",
      "state": "N/A",
      "country": "Sweden",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80515",
      "recalling_firm": "RAYSEARCH LABORATORIES AB",
      "address_1": "Sveavagen 9",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-2554-2018",
      "product_description": "RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0    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": "718",
      "reason_for_recall": "The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters  affect the dose calculated in corners of large or off-axis fields. This effect cannot be seen in the Beam Commissioning module and dose in large or off-axis fields needs to be validated using the Beam 3D Modeling module in RayPhysics/RayPlan Physics. The user must  be aware to avoid incorrect dose calculations during treatment planning.",
      "recall_initiation_date": "20180606",
      "center_classification_date": "20180726",
      "termination_date": "20190404",
      "report_date": "20180801",
      "code_info": "2.5.1.89 ,  3.5.0.16 ,  3.5.1.6 ,  4.0.0.14 ,  4.0.1.4  4.0.2.9 ,  4.0.3.4 ,  4.3.0.14 ,  4.5.0.19 ,  4.5.1.14 ,  4.5.2.7 ,  4.7.0.15 ,  4.7.1.10 ,  4.7.2.5 ,  4.7.3.13 ,  4.7.4.4 ,  4.7.5.4 ,  4.9.0.42 ,  5.0.0.37 ,  5.0.1.11 ,  5.0.2.35,   6.0.0.24 ,  6.1.0.26 ,  6.1.1.2 ,  6.2.0.7 ,  7.0.0.19 ."
    }
  ]
}