{
  "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": "Completed",
      "city": "Maastricht-Airport",
      "state": "N/A",
      "country": "Netherlands",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77025",
      "recalling_firm": "CardioTek BV",
      "address_1": "Amerikalaan 70",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) to states of: CA, IL, OH, and MN; and countries of: Albania, Algeria, Argentina, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cuba, Czech Rep, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Monaco, Morocco, Netherlands, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Rep. Dominicana, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad & Tobago, Turkey, United Arab Emirates, United Kingdom, Venezuela and Vietnam.",
      "recall_number": "Z-2657-2017",
      "product_description": "CardioTek EP-TRACER Software V1.x and V2.0    The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.",
      "product_quantity": "8 units US",
      "reason_for_recall": "Software bug which allows parameters to be changed unintentionally during use.",
      "recall_initiation_date": "20170413",
      "center_classification_date": "20170630",
      "report_date": "20170712",
      "code_info": "All EP-Tracer -FSCA-identifier (2017-04-06)"
    }
  ]
}