{
  "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-1194-2025",
      "product_description": "Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System  Model/Catalog Number: 5.0.2.35 and 5.0.3.17  Software Version: RayStation 5 Service Pack 2 and 3",
      "product_quantity": "0",
      "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: 0735000201002020170502 GTIN: 07350002010020 Serial Numbers: 5.0.2.35 and 5.0.3.17 Software Revisions: RayStation 5 Service Pack 2 and 3 Expiration Date: 2028-12-21"
    }
  ]
}