{
  "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": "84705",
      "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": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in states of 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, WI",
      "recall_number": "Z-0866-2020",
      "product_description": "RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.",
      "product_quantity": "3114 Devices/Licenses",
      "reason_for_recall": "Three issues found: i) \tThe Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of our knowledge, these issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.",
      "recall_initiation_date": "20191219",
      "center_classification_date": "20200204",
      "termination_date": "20201124",
      "report_date": "20200205",
      "code_info": "Software Versions Numbers:  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 ,  6.3.0.6 ,  7.0.0.19 ,  8.0.0.61 ,  8.0.1.10 ,  8.1.0.47 ,    8.1.1.8 , 8.1.2.5 ,  9.0.0.113 ."
    }
  ]
}