{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "158643",
      "product_res_number": "Z-0049-2018",
      "event_date_initiated": "2017-08-14",
      "event_date_created": "2017-10-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-08-04",
      "res_event_number": "78092",
      "product_code": "PLP",
      "k_numbers": [
        "K153023"
      ],
      "product_description": "Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation\n\n Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue",
      "code_info": "Serial Numbers:  AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267",
      "firm_fei_number": "1287394",
      "recalling_firm": "Edap Technomed Inc.",
      "address_1": "5321 Industrial Oaks Blvd Ste 110 5321 Industrial Oaks Blvd",
      "address_2": "Ste 110",
      "city": "Austin",
      "state": "TX",
      "postal_code": "78735-8823",
      "additional_info_contact": "Hugo Embert\n512-832-7956",
      "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.",
      "root_cause_description": "Other",
      "action": "The firm, EDAP TMS,  company contacted all affected customers by phone during the week of August 14, 2017 and followed up with an \" URGENT FIELD SAFETY NOTICE\" letter dated 8/22/2017 delivered by email on 08/29/2016.  The letter described the product, problem and actions to be taken. The customers were instructed  as follows: do not use the \"medium\" or \"low\"  energy treatment power settings in the meantime.The devices will be serviced at the consignee to remove Protocols \"02-medium\" and \"03-low\". \n\nIf you have any questions regarding this notification, or experience any issues with your device, please contact EDAP TMS Customer Care Center at (512) 852-9685 or via email at service@edap-usa.com at any time, 24 hours a day, 7 days a week.",
      "product_quantity": "12 units",
      "distribution_pattern": "US Distribution to states of: NY, FL CA, NC, TX and NJ.",
      "openfda": {
        "device_name": "High Intensity Ultrasound System For Prostate Tissue Ablation",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4340",
        "device_class": "2",
        "k_number": [
          "K153023",
          "K202286",
          "K212150",
          "K191200",
          "K160942",
          "DEN150011",
          "K230692",
          "K240296",
          "K172721",
          "K251910",
          "K172285",
          "K231378",
          "K211858"
        ],
        "registration_number": [
          "9612448",
          "3007126306",
          "9615058",
          "3012604011",
          "1287394",
          "2951226",
          "1319639",
          "1450662"
        ],
        "fei_number": [
          "3007126306",
          "3012604011",
          "3003105983",
          "1287394",
          "3002132857",
          "1000138054",
          "1450662",
          "3002806876"
        ]
      }
    }
  ]
}