{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Export",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77176",
      "recalling_firm": "Circadiance LLC",
      "address_1": "1060 Corporate Ln",
      "address_2": "N/A",
      "postal_code": "15632-8905",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution.",
      "recall_number": "Z-2250-2017",
      "product_description": "SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE.    Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.",
      "product_quantity": "1,242 units",
      "reason_for_recall": "Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature.  The firm has updated the device to increase the \"Nurse Call\" feature to ensure monitor alarms are transmitted to compatible nurse call systems.",
      "recall_initiation_date": "20170501",
      "center_classification_date": "20170606",
      "termination_date": "20180205",
      "report_date": "20170614",
      "code_info": "Unique Device Identifier (UDI) 1030271, 1038140, 1038141, U1030271, and U1038140.    All serial numbers of units with \"REF\", \"MODEL\" or standalone part number 1030271, 1038140, 1038141, U1030271 or U1038140 located on the products label are impacted by this notice.  Monitors with the above part numbers that have a serial number starting with \"CP\" are NOT affected by this issue."
    }
  ]
}