{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Orlando",
      "address_1": "12151 Research Pkwy Ste 200",
      "reason_for_recall": "The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate.  Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2010 device, the FC2020 device, which is used in the Pre or Post-Op Holding Areas, is not impacted by this issue.",
      "address_2": "",
      "product_quantity": "4375 units",
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      "center_classification_date": "20180514",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico., and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Italy, Kazakhstan, Kenya, Malaysia, Mexico, Mauritius, Netherlands, New Zealand, Pakistan, Philippines, Poland, Romania, Russian Fed, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, Utd. Arab Emir, Uzbekistan and Vietnam.",
      "state": "FL",
      "product_description": "PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers:  453564241901, 453564483321, 453564621791, and 989803199561 (international only)  The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers.",
      "report_date": "20180523",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Invivo Corporation",
      "recall_number": "Z-1867-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79611",
      "termination_date": "20210430",
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      "recall_initiation_date": "20180314",
      "postal_code": "32826-3286",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}