{
  "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": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71404",
      "recalling_firm": "Volcano Corp",
      "address_1": "3721 Valley Centre Dr Ste 500",
      "address_2": "N/A",
      "postal_code": "92130-3328",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.",
      "recall_number": "Z-2044-2015",
      "product_description": "Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging  and Pressure System;  Product/Part numbers: s5i -806300-020 ;  s5ix/s5iz -  807400-001;  CORE -  400-0 I 00.02.      Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.",
      "product_quantity": "227 total units - all models",
      "reason_for_recall": "A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.",
      "recall_initiation_date": "20130923",
      "center_classification_date": "20150708",
      "termination_date": "20150709",
      "report_date": "20150715",
      "code_info": "Product/Part numbers: s5i -806300-020 ;  s5ix/s5iz -  807400-001;  CORE -  400-0 I 00.02.      All software versions"
    }
  ]
}