{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "30682",
      "product_res_number": "Z-0232-04",
      "event_date_initiated": "2003-12-05",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-10-05",
      "res_event_number": "27882",
      "product_code": "MAA",
      "product_description": "Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is labeled as: Sonotrax Handheld Fetal Doppler Series and includes  the Basic and Lite models.",
      "code_info": "Product is uncoded.",
      "firm_fei_number": "1000541224",
      "recalling_firm": "Danatech Medical Systems Inc",
      "address_1": "7275 Nw 68th St Ste 1 7275 Nw 68th St",
      "address_2": "Ste 1",
      "city": "Miami",
      "state": "FL",
      "postal_code": "33166-3094",
      "additional_info_contact": "Luis F. Guevara\n305-883-9716",
      "reason_for_recall": "This prescription device, without an approved 510K , was distributed to unauthorized consumers, mostly pregnant women, on the internet.",
      "root_cause_description": "Other",
      "action": "The firm mailed via overnight priority mail, a recall notification letter with response form to consignees on 12/5/2003 requesting return of the product and refund.",
      "product_quantity": "89 units",
      "distribution_pattern": "Product was distributed to 89 consumers nationwide.",
      "openfda": {
        "k_number": [
          "K102138",
          "K915138",
          "K905456",
          "K905536",
          "K904600",
          "K904951",
          "K894992",
          "K895909",
          "K090499"
        ],
        "registration_number": [
          "1216677"
        ],
        "fei_number": [
          "1216677"
        ],
        "device_name": "Monitor, Fetal Doppler Ultrasound",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.2660",
        "device_class": "2"
      }
    }
  ]
}