{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Rancho Cordova",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71654",
      "recalling_firm": "Volcano Corporation",
      "address_1": "2870 Kilgore Rd",
      "address_2": "N/A",
      "postal_code": "95670-6133",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution-US (nationwide) and regions in Europe and the countries of  Japan, Canada, South Africa, Taiwan, Thailand, Singapore, Philippines, Australia, New Zealand, El Salvador, Malaysia, Mexico, Lebanon, Kuwait, South Korea, Kenya, Jordan, Iran, India, Israel, Hong Kong, Egypt, Algeria, Dominican Republic, Costa Rica, Chile, Brazil, Bolivia, and Argentina",
      "recall_number": "Z-2132-2015",
      "product_description": "Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits;    Model s5x.      Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature",
      "product_quantity": "A total of 4007 devices, all models",
      "reason_for_recall": "A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.",
      "recall_initiation_date": "20150622",
      "center_classification_date": "20150720",
      "termination_date": "20170414",
      "report_date": "20150729",
      "code_info": "Model s5x.  Part number: 807300-001."
    }
  ]
}