{
  "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": "Terminated",
      "city": "WAYNE",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83233",
      "recalling_firm": "GETINGE US SALES LLC",
      "address_1": "45 BARBOUR POND DR",
      "address_2": "N/A",
      "postal_code": "07470",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of MD, OK, NY,FL, SC",
      "recall_number": "Z-2077-2019",
      "product_description": "PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0.    Usage:  The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed. ¿ -With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters. -With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption. The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units",
      "product_quantity": "7",
      "reason_for_recall": "The monitor displays an error message . The error message states  \"internal error restart or service\".",
      "recall_initiation_date": "20190605",
      "center_classification_date": "20190725",
      "termination_date": "20200424",
      "report_date": "20190731",
      "code_info": "software version:V5.1.0.7 US ver. A.,     Serial number affected: K17400011005 , K17400011065, K17400011082, K17400011086, K17400011097, K17400011107, L17400011267."
    }
  ]
}