{
  "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": "Ongoing",
      "city": "Stockholm",
      "state": "N/A",
      "country": "Sweden",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89631",
      "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.",
      "recall_number": "Z-0732-2022",
      "product_description": "RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy.  Software Version:  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 ,  9.1.0.933 ,  9.2.0.483 .  Including Service Paks:  Product name (build number) UDI-DI  RayStation 6/RayPlan 2 (6.0.0.24) 07350002010013  RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082  RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075  RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242  RayStation/RayPlan 7 (7.0.0.19) 07350002010068  RayStation/RayPlan 8A (8.0.0.61) 07350002010112  RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136  RayStation/RayPlan 8B (8.1.0.47) 07350002010129  RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204  RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235  RayStation/RayPlan 9A (9.0.0.113) 07350002010174  RayStation/RayPlan 9B (9.1.0.933) 07350002010266  RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297",
      "product_quantity": "75 Licenses",
      "reason_for_recall": "If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running",
      "recall_initiation_date": "20211230",
      "center_classification_date": "20220308",
      "report_date": "20220316",
      "code_info": "Software:  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, 9.1.0.933, 9.2.0.483  UDI: 07350002010013 07350002010082 07350002010075 07350002010242 07350002010068 07350002010112 07350002010136 07350002010129 07350002010204 07350002010235 07350002010174 07350002010266 07350002010297 07350002010013 07350002010082 07350002010075 07350002010242 07350002010068"
    }
  ]
}