{
  "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": "88258",
      "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 distribution to TN; and Belgium",
      "recall_number": "Z-2138-2021",
      "product_description": "RayStation (Radiation Treatment Planning System) :  RayStation 9A, 9B, 9B SP1, 10A, 10A  SP1, 10B and 11A, in combination with RayCare  Model Numbers/ UDI:  RayStation 9.0 (9.0.0.113)   07350002010174;  RayStation 9.1 (9.1.0.933)   07350002010266;  RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297;  RayStation 10.0 (10.0.0.1154) 07350002010303;  RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365;  RayStation 10.1 (10.1.0.613) 07350002010310;  RayStation 11.0 (11.0.0.951) 07350002010389;",
      "product_quantity": "5 units",
      "reason_for_recall": "Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.",
      "recall_initiation_date": "20210608",
      "center_classification_date": "20210723",
      "termination_date": "20240320",
      "report_date": "20210804",
      "code_info": "Product name (build number) UDI-DI RayStation 9.0 (9.0.0.113) 07350002010174 RayStation 9.1 (9.1.0.933) 07350002010266 RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297 RayStation 10.0 (10.0.0.1154) 07350002010303 RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365 RayStation 10.1 (10.1.0.613) 07350002010310 RayStation 11.0 (11.0.0.951) 07350002010389"
    }
  ]
}