{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Madison",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "67947",
      "recalling_firm": "INO Therapeutics (dba Ikaria)",
      "address_1": "2902 Dairy Dr",
      "address_2": "N/A",
      "postal_code": "53718-3809",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including DC and VA.",
      "recall_number": "Z-1528-2014",
      "product_description": "INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0.  The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.",
      "product_quantity": "22",
      "reason_for_recall": "An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0).  When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur.  In addition, an unintended NO2 cell failure alarm may also occur.  The NO/NO2 cell failure alarms are caused by an average NO/NO2 circuit concentration greater tha",
      "recall_initiation_date": "20140327",
      "center_classification_date": "20140502",
      "termination_date": "20141121",
      "report_date": "20140514",
      "code_info": "Serial Numbers:  DS20080152, DS20090218, DS20090243, DS20090271, DS20090523, DS20090598, DS20090821, DS20090925, DS20101022, DS20101076, DS20101147, DS20101374, DS20101413, DS20101420,   DS20101499, DS20101637, DS20111199, DS20120099, DS20120150, DS20120169, DS20120288, DS20120306."
    }
  ]
}