{
  "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": "Mountain View",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69855",
      "recalling_firm": "Hansen Medical Inc",
      "address_1": "800 E Middlefield Rd",
      "address_2": "N/A",
      "postal_code": "94043-4030",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.",
      "recall_number": "Z-0896-2015",
      "product_description": "Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table.    Product Usage:     The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen Medical\u0019s robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems.",
      "product_quantity": "59 USA, 40 OUS",
      "reason_for_recall": "The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table with the potential for the device to fall causing, uncontrolled catheter movement. cardiac tampenade, delayed procedure, or crush injury to the patient and/or user.",
      "recall_initiation_date": "20141204",
      "center_classification_date": "20141230",
      "termination_date": "20150903",
      "report_date": "20150107",
      "code_info": "Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action."
    }
  ]
}