{
  "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": "87977",
      "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": "Worldwide distribution - US Nationwide distribution in the states of AK, AL, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, Colombia, Czech Republic, Denmark, Egypt, Estonia, France, French Polynesia, Germany, Hong Kong, China, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK,",
      "recall_number": "Z-1838-2021",
      "product_description": "RayStation (Treatment Planning System)  Model Number\tRayStation is  6.0.0.24 ,  6.1.1.2 ,  6.2.0.7 ,  6.3.0.6 ,  7.0.0.19 ,  8.0.0.6 ,  8.0.1.10 ,  8.1.0.47 ,  8.1.1.8 ,  8.1.2.5 ,  9.0.0.113 ,  9.1.0.933 ,  9.2.0.483 ,  10.0.0.1154 ,  10.0.1.52  or  10.1.0.613 .",
      "product_quantity": "Domestic: 13,722 systems",
      "reason_for_recall": "Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices is d 1 mm, present in RayStation/RayPlan versions from 6 up to 10A.",
      "recall_initiation_date": "20210421",
      "center_classification_date": "20210609",
      "termination_date": "20230727",
      "report_date": "20210616",
      "code_info": "Software version: RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 2 including some service packs."
    }
  ]
}