{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Houston",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71056",
      "recalling_firm": "Hitachi America, Ltd., Power Systems Division",
      "address_1": "1840 Old Spanish Trl",
      "address_2": "N/A",
      "postal_code": "77054-2002",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distribution in US (Texas) and Japan",
      "recall_number": "Z-1838-2015",
      "product_description": "PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM    Product Usage:  Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.",
      "product_quantity": "3",
      "reason_for_recall": "At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation.  The irradiation control system may be potentially affected when rebooting a part of the control system.",
      "recall_initiation_date": "20150421",
      "center_classification_date": "20150717",
      "termination_date": "20160324",
      "report_date": "20150729",
      "code_info": "No serial number or lot code. Each system is designed for a specific facility therefore no codes are needed for traceability"
    }
  ]
}