{
  "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": "N/A",
      "country": "Sweden",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96156",
      "recalling_firm": "RAYSEARCH LABORATORIES AB",
      "address_1": "Eugeniavagen 18c",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,  Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain,  SwitzerlandENG, Taiwan, Thailand, UK.",
      "recall_number": "Z-1190-2025",
      "product_description": "Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System  Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119  Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1",
      "product_quantity": "5",
      "reason_for_recall": "Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.",
      "recall_initiation_date": "20250116",
      "center_classification_date": "20250219",
      "report_date": "20250226",
      "code_info": "Lot Code: UDI: 0735000201042620211208,  0735000201049520220312, 0735000201050120220422,  0735000201060020220620 and 0735000201057020221222 GTIN: 07350002010426,  07350002010495, 07350002010501, 07350002010600 and 07350002010570 Serial Numbers: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Revisions: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1 Expiration Date: 2028-03-20"
    }
  ]
}