{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Sesto Fiorentino",
      "state": "N/A",
      "country": "Italy",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81285",
      "recalling_firm": "ESAOTE S.P.A.",
      "address_1": "Sesto Fiorentino",
      "address_2": "Via Degli Olmi 11",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide in the states of AK, AZ, CA, IN, MO, NM, PA, SC, and TX. and countries Argentina and  Australia  Austria  Bangladesh  Belgium  Brazil  Bulgaria  China  Costa Rica  Denmark  Egypt  Finland  France  Germany  Greece  Hong Kong  Hungary  Iceland  India  Iran  Italy  Japan  Kuwait  Mexico  Netherlands  Norway  Paraguay  Poland  Portugal  Russian Fed.  Saudi Arabia  Singapore  Slovenia  South Africa  South Korea  Spain  Switzerland  Taiwan  Thailand  Tunisia  Turkey  United Kingdom  Utd.Arab Emir.",
      "recall_number": "Z-0206-2019",
      "product_description": "MyLab Seven, Model 6400",
      "product_quantity": "10",
      "reason_for_recall": "The probe power monitoring settings have been found to be not appropriate under  specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue.",
      "recall_initiation_date": "20180611",
      "center_classification_date": "20181023",
      "termination_date": "20200512",
      "report_date": "20181031",
      "code_info": "n/a"
    }
  ]
}