{
  "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": "Andover",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "67046",
      "recalling_firm": "Philips Medical Systems, Inc.",
      "address_1": "3000 Minuteman Rd",
      "address_2": "N/A",
      "postal_code": "01810-1032",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide and OUS.",
      "recall_number": "Z-0570-2014",
      "product_description": "Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement     The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. The HeartStart MRx EtCO2 Option monitors carbon dioxide (CO2) and measures end-tidal carbon dioxide (EtCO2). The option provides an EtCO2 value and a CO2 waveform on the devices display.",
      "product_quantity": "18,529 units",
      "reason_for_recall": "MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg",
      "recall_initiation_date": "20131210",
      "center_classification_date": "20131224",
      "termination_date": "20170418",
      "report_date": "20140101",
      "code_info": "Software versions: F.02, R.02, 9.xx or any earlier versions     Addendum Models: M3532A, M3535A, M3536AM, M3536MC, M3536M2, M3536M4,  M3536M5,  M3536M6  M3535A- HeartStart MRx Defibrillator Monitor  M3536A- HeartStart MRx Defibrillator Monitor  EtC02 Options  A04  A05  A06  All  M3532A Upgrade",
      "more_code_info": ""
    }
  ]
}