{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Austin",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78092",
      "recalling_firm": "Edap Technomed Inc.",
      "address_1": "5321 Industrial Oaks Blvd Ste 110",
      "address_2": "N/A",
      "postal_code": "78735-8823",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "US Distribution to states of: NY, FL CA, NC, TX and NJ.",
      "recall_number": "Z-0049-2018",
      "product_description": "Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation     Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue",
      "product_quantity": "12 units",
      "reason_for_recall": "The US FDA has requested the optional energy treatment settings, \"medium\" and \"low\" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining devices in the U.S. until supporting clinical data can be submitted and evaluated by FDA.",
      "recall_initiation_date": "20170814",
      "center_classification_date": "20171026",
      "termination_date": "20200804",
      "report_date": "20171101",
      "code_info": "Serial Numbers:  AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267"
    }
  ]
}