{
  "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": "Stockholm",
      "state": "",
      "country": "Sweden",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80459",
      "recalling_firm": "RAYSEARCH LABORATORIES AB",
      "address_1": "Sveavagen 9",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide Distribution to accounts in AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.",
      "recall_number": "Z-2497-2018",
      "product_description": "RayStation stand-alone software treatment planning system,  RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A)    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": "746",
      "reason_for_recall": "If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when  the collimator is rotated. This could lead to potentially significant overdosage at delivery. The user must be aware of the issue to avoid incorrect dose calculations during treatment planning.",
      "recall_initiation_date": "20180629",
      "center_classification_date": "20180719",
      "termination_date": "20200716",
      "report_date": "20180725",
      "code_info": "Software Versions  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 , 5.0.2.3 ,  6.0.0.24 ,  6.1.0.26 ,  6.1.1.2 ,  6.2.0.7 ,  7.0.0.19 ,  8.0.0.61",
      "more_code_info": ""
    }
  ]
}