{
  "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": "Santa Clara",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94928",
      "recalling_firm": "Hitachi America, Ltd., Particle Therapy Division",
      "address_1": "2535 Augustine Dr, 2nd fl",
      "address_2": "",
      "postal_code": "95054",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide distribution in the states of TN, TX, and WA.",
      "recall_number": "Z-3126-2024",
      "product_description": "Brand Name: PROBEAT  Product Name: PROBEAT-CR  Model/Catalog Number: N/A  Software Version: N/A  Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton   beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose,   dose distribution and directed to the prescribed patient treatment site.  Component: N/A",
      "product_quantity": "1",
      "reason_for_recall": "During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.",
      "recall_initiation_date": "20240527",
      "center_classification_date": "20240912",
      "report_date": "20240918",
      "code_info": "Lot Code: (01)04560333350006(21)CRUS01(11)190920",
      "more_code_info": ""
    }
  ]
}