{
  "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": [
    {
      "status": "Ongoing",
      "city": "Andover",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81531",
      "recalling_firm": "Philips Electronics North  America Corporation",
      "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 distribution.",
      "recall_number": "Z-0592-2019",
      "product_description": "IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.",
      "product_quantity": "35469 units",
      "reason_for_recall": "A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the  performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may  intermittently exhibit  Speaker Malfunct  INOP messages after the Power On  Self-Test.  The issue is only apparent when the device is being used in Monitor Mode at an  altitude of greater than 4,500 feet.",
      "recall_initiation_date": "20181010",
      "center_classification_date": "20181210",
      "report_date": "20181219",
      "code_info": "All devices manufactured or repaired from 21-FEB-2017 to 22-AUG -2018. (Serial numbers included as an attachment; too many to list.)"
    }
  ]
}