{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Andover",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91938",
      "recalling_firm": "Draeger Medical Systems, Inc.",
      "address_1": "6 Tech Dr",
      "address_2": "N/A",
      "postal_code": "01810-2434",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution.",
      "recall_number": "Z-1472-2023",
      "product_description": "Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,",
      "product_quantity": "19,429 systems",
      "reason_for_recall": "The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.",
      "recall_initiation_date": "20230405",
      "center_classification_date": "20230427",
      "report_date": "20230503",
      "code_info": "UDI-DI: 04049098048989 (M300), 04049098095778 (M300+); All Systems Running Software versions: VG2.4 and lower"
    }
  ]
}