{
  "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": [
    {
      "country": "United States",
      "city": "Foothill Ranch",
      "address_1": "90 Icon",
      "reason_for_recall": "Medical device non-conformance to electrical safety standard (IEC 60601-1).",
      "address_2": "",
      "product_quantity": "189 Units",
      "code_info": "Serial numbers 3.   Serial numbers 320, 470, 507, 534, 621, 757, 770, 795, 892, 1165-1183, 1186- 1205, 1214-1293, 1295-1297, 1304-1330, 1333-1342, 1358 -1384, 1387-1389, 1391-1413, 1421-1430, 1434-1505, 1507- 1516.",
      "center_classification_date": "20210114",
      "distribution_pattern": "US Nationwide Distribution - CA, CO, CT, FL, ID, IL, IN, MA, MD, MI, MO, NC, NM, NY, SC, TX, TN, UT, VA, VT and WA.",
      "state": "CA",
      "product_description": "PSG-1100 Sleep Diagnostic System.    Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan    The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.",
      "report_date": "20210203",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Nihon Kohden America Inc",
      "recall_number": "Z-0865-2021",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "87011",
      "more_code_info": "",
      "recall_initiation_date": "20201221",
      "postal_code": "92610-3000",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}