{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Mettawa",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92243",
      "recalling_firm": "Vyaire Medical",
      "address_1": "26125 N Riverwoods Blvd",
      "address_2": "N/A",
      "postal_code": "60045-3420",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide Distribution",
      "recall_number": "Z-1966-2023",
      "product_description": "bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator",
      "product_quantity": "910 units",
      "reason_for_recall": "Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e:  1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states  DeviceSoftware.Application is not responding  or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error.  2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.",
      "recall_initiation_date": "20230505",
      "center_classification_date": "20230614",
      "report_date": "20230621",
      "code_info": "UDI/DI: 10190752197664 and 07640149381115, ALL serial numbers with Software Version 6.1.0.2 and 6.1.1"
    }
  ]
}