{
  "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": "97400",
      "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": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.",
      "recall_number": "Z-2488-2025",
      "product_description": "RayStation with the following product descriptions:     1. RayStation 8B, Software Version: 8.1.0.47.    2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8.    3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5.    4. RayStation 9A, Software Version: 9.0.0.113.    5. RayStation 9A Service Pack 1, Software Version: 9.0.1.142.      Product Description: Radiation Therapy Treatment Planning System.",
      "product_quantity": "2",
      "reason_for_recall": "DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.",
      "recall_initiation_date": "20250808",
      "center_classification_date": "20250902",
      "report_date": "20250910",
      "code_info": "1. Software Version: 8.1.0.47, UDI: 0735000201012920181209.  2. Software Version: 8.1.1.8, UDI: 0735000201020420190214.  3. Software Version: 8.1.2.5, UDI: 0735000201023520190524.  4. Software Version: 9.0.0.113, UDI: 0735000201017420190612.  5. Software Version: 9.0.1.142, UDI: 0735000201048820220420.   Expiration Date: 2027-12-15"
    }
  ]
}