{
  "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": "Hartland",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76974",
      "recalling_firm": "Merge Healthcare, Inc.",
      "address_1": "900 Walnut Ridge Dr",
      "address_2": "N/A",
      "postal_code": "53029-8347",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Distribution was nationwide.  There was also government and military distribution.  There was no foreign distribution.",
      "recall_number": "Z-2641-2017",
      "product_description": "Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047),     Product Usage:  Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.",
      "product_quantity": "2 sensors",
      "reason_for_recall": "Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.",
      "recall_initiation_date": "20160404",
      "center_classification_date": "20170629",
      "termination_date": "20191015",
      "report_date": "20170705",
      "code_info": "The following lot numbers are affected and are not specific to each cable/sensor type:      09AP8, 10AEU, 10KBN, 09CF9, 10BMN, 10MDN, 09CNS, 10FEN, 10MDN, 09KG6, 10F95, 10DUT, 09KG6, 10F95, 10DDK, 09NMN, 10BMN, 10DUT, 10A81, 10GJB, 10KBS, 09NMN, 10BMN, 10DUT, 10AEU, 10GJB, 10KBS, 10AEU, 10KBN, 10KBS, 11AGS, 11KAJ, 11CFT, 10KFP, 11N61, 11DAY, 11AGS, 11NG2, 11CFT, 11AGS, 12CNX, 11DDK, 12FMH, 12C68, 11FBS, 12GEB, 12C68, 11JBK, 12GEB,  and 12FMH."
    }
  ]
}