{
  "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": "Rancho Cordova",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83919",
      "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": "Distribution was nationwide.  There was government/military distribution.    Foreign distribution was made to Canada, Austria, Australia, Badajoz, Bahrain,   Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Ireland, Israel, Italy, Jordan, Japan, Korea, Republic of, Lebanon, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.",
      "recall_number": "Z-0674-2020",
      "product_description": "Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i Imaging System, Part#806300003; (4) s5i Imaging System, Part#5322466; (5) s5x Imaging System, Part#807300001; (6) s5x Imaging System Refurbished, Pat#807300001 R; (7) s5 Imaging System Refurbished, Part#804200001 R; (8) CORE Mobile Imaging System (120V), Part #400-0100.01; (9) CORE Mobile Imaging System Refurbished, Part #400-0100.01-R; (10) CORE Mobile Imaging System (240V), Part #400-0100.07; (11) CORE Mobile Imaging System Refurbished, Part #400-0100.07-R; (12) CORE Mobile Imaging System (100V), Part #400-0100.08; (13) CORE Mobile Imaging System Refurbished, Part #400-0100.08-R; and (14) CORE Imaging System, Part #400-0100.02; (15) CORE Integrated Imaging System Refurbished, Part#400 0100.02 R.",
      "product_quantity": "3,667 units with software",
      "reason_for_recall": "Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).",
      "recall_initiation_date": "20181107",
      "center_classification_date": "20191212",
      "termination_date": "20220714",
      "report_date": "20191218",
      "code_info": "FFR V2.5 Software Kit, Catalog 4536-010-57091 (Legacy 435-0602.48) and FFR V2.5 Update Installation Disk, Catalog 4536-010-52781 (Legacy 435-0100.98)",
      "more_code_info": ""
    }
  ]
}