{
  "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": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92441",
      "recalling_firm": "RaySearch America Inc",
      "address_1": "350 5th Ave Ste 5000",
      "address_2": "The Empire State Building",
      "postal_code": "10118-0110",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US: AZ, CA, GA & WA",
      "recall_number": "Z-2039-2023",
      "product_description": "Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.",
      "product_quantity": "5 systems",
      "reason_for_recall": "A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.",
      "recall_initiation_date": "20210122",
      "center_classification_date": "20230629",
      "termination_date": "20230703",
      "report_date": "20230705",
      "code_info": "UDI-DI: 07350002010129  UDI-DI: 07350002010204  UDI-DI: 07350002010235  UDI-DI: 07350002010174  UDI-DI: 07350002010266  UDI-DI: 07350002010297  UDI-DI: 07350002010303  UDI-DI: 07350002010365  UDI-DI: 07350002010310",
      "more_code_info": ""
    }
  ]
}