{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "30843",
      "product_res_number": "Z-0345-04",
      "event_date_initiated": "2003-12-10",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-11-15",
      "res_event_number": "27983",
      "product_code": "MEQ",
      "pma_numbers": [
        "P950014"
      ],
      "product_description": "Prostatron Praktis Type II for Transurethral Microwave Thermotherapy.  The Prostatron is a computer-controlled device designed to deliver microwave energy to the prostrate for the treatment of BPH (Benign Prostatic Hyperplasia).  The Prostatron utilizes a transurethral microwave antenna, with simultaneous urethral cooling, to heat the prostate.  This heating process is regulated through feedback from a series of temperature sensors.",
      "code_info": "Serial numbers PP80023 through PP80040 and PP037 through PP180",
      "firm_fei_number": "3000718675",
      "recalling_firm": "Urologix, Inc.",
      "address_1": "14405 21st Ave N",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55447-4685",
      "additional_info_contact": "Tod Paulson\n763-475-4100",
      "reason_for_recall": "During treatments, using the Prostatron units, the devices' Temperature Sensing System may change the rectal temperature reading by up to 2 degrees Celsius and may briefly delay updates to the rectal temperature reading.",
      "root_cause_description": "Other",
      "action": "A letter about the problem, actions to take to avoid the problem, and the proposed software correction was sent to consignees on December 10, 2003.   A software upgrade will be performed on all units in  March 2004.",
      "product_quantity": "146 units",
      "distribution_pattern": "The product was shipped to consignees located nationwide in the United States and to foreign consignees in Australia, France and Japan.",
      "openfda": {
        "pma_number": [
          "P970008",
          "P030006",
          "P950014",
          "P010055",
          "P970044",
          "P000043"
        ],
        "registration_number": [
          "1721676",
          "3009969279",
          "2183744",
          "2183967",
          "3007029079",
          "2133936",
          "2025851",
          "3010806653"
        ],
        "fei_number": [
          "1721676",
          "3009969279",
          "2183744",
          "3000718675",
          "3007029079",
          "1000115735",
          "2025851",
          "3010806653"
        ],
        "device_name": "System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}