{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Stockholm",
      "state": "",
      "country": "Sweden",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98117",
      "recalling_firm": "RAYSEARCH LABORATORIES AB",
      "address_1": "Eugeniavagen 18c",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS",
      "recall_number": "Z-1109-2026",
      "product_description": "Brand Name: RayStation  Product Name: RayStation/RayPlan  Model/Catalog Number: 16.0.0  Software Version: RayStation 2024B  Product Description: Radiation Therapy Treatment Planning System  Component: No",
      "product_quantity": "0",
      "reason_for_recall": "Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.",
      "recall_initiation_date": "20251128",
      "center_classification_date": "20260116",
      "report_date": "20260128",
      "code_info": "Lot Code: UDI: 0735000201077820240625 GTIN: 07350002010778 Serial Numbers: 16.0.0.847 Software Revision: RayStation 2024B Expiration Date: 2029-06-28",
      "more_code_info": ""
    }
  ]
}