{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Maastricht-Airport",
      "state": "",
      "country": "Netherlands",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90154",
      "recalling_firm": "CardioTek BV",
      "address_1": "Amerikalaan 70",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of CA, NY, NC and the countries of South Korea, Mexico, Kazakhstan, Netherlands, Spain, Germany, Finland, Poland, Israel, Turkey, Chile, Ecuador, Austria, Croatia, Sweden, United Kingdom, Colombia, Italy, Portugal, Canada, Saudi Arabia, Belgium, Slovenia, Brazil, Hungary, Malaysia, Uzbekistan.",
      "recall_number": "Z-1283-2022",
      "product_description": "CardioTek EP-TRACER Software V2.x.",
      "product_quantity": "146 units",
      "reason_for_recall": "Device did not pass electrical safety testing for adequate insulation.",
      "recall_initiation_date": "20220425",
      "center_classification_date": "20220623",
      "report_date": "20220629",
      "code_info": "EP-TRACER 38 UDI/DI: 04260441455418; Serial Numbers: 2019-1-01, 2019-1-02, 2019-1-03, 2019-1-04, 2019-1-05, 2019-1-06, 2019-2-01, 2019-2-02, 2019-2-03, 2019-2-04, 2019-2-05, 2019-3-01, 2019-3-02, 2019-3-03, 2019-3-04, 2019-3-05, 2019-3-06, 2019-3-07, 2019-3-08, 2019-3-09, 2019-3-10, 2019-4-01, 2019-4-02, 2019-4-03, 2019-4-04, 2019-4-05, 2019-4-06, 2019-4-07, 2019-4-08, 2019-4-09, 2019-4-10, 2019-5-01, 2019-5-02, 2019-5-03, 2019-5-04, 2019-5-05, 2020-1-01, 2020-1-02, 2020-1-03, 2020-1-04, 2020-1-05, 2020-1-06, 2020-1-07, 2020-1-08, 2020-1-09, 2020-1-10, 2020-1-11, 2020-1-12, 2020-1-13, 2020-1-14, 2020-1-15, 2020-2-01, 2020-2-02, 2020-2-03, 2020-2-04, 2020-2-05, 2020-2-06, 2020-2-07, 2020-2-08, 2020-2-09, 2020-2-10, 2020-2-11, 2020-2-13, 2020-2-14, 2020-2-15, 2020-4-01, 2020-4-02, 2020-4-03, 2020-4-04, 2021-1-01, 2021-1-02, 2021-1-03, 2021-1-04, 2021-1-05, 2021-1-06, 2021-1-07, 2021-1-08, 2021-2-01, 2021-2-02, 2021-2-03, 2021-2-04, 2021-2-06, 2021-2-07, 2021-2-08, 2021-2-09, 2021-2-10, 2021-2-11, 2021-2-12, 2021-2-13, 2021-2-14, 2021-2-15, 2021-3-01, 2021-3-02, 2021-3-03, 2021-3-04, 2021-3-05, 2021-3-06, 2021-3-07, 2021-3-08, 2021-3-09, 2021-3-10, 2021-3-11, 2021-3-12, 2021-3-13, 2021-3-14, 2021-3-15, 2021-5-01, 2021-5-02, 2021-5-03, 2021-5-04, 2021-5-05, 2021-5-06, 2022-1-01, 2022-1-03, 2022-1-04, 2022-1-05, 2022-1-06;  EP-TRACER 102 UDI/DI: 04260441455234; Serial Numbers: 2019-1-11, 2019-2-11, 2019-2-12, 2019-2-13, 2019-2-14, 2019-2-15, 2019-2-16, 2019-4-21, 2019-4-22, 2019-4-23, 2019-4-24, 2019-4-25, 2019-4-26, 2019-4-27, 2020-1-26, 2020-1-27, 2020-1-28, 2020-1-29, 2020-1-30, 2020-2-26, 2020-2-27, 2020-2-28, 2020-2-29, 2020-2-30, 2021-1-13, 2021-1-14, 2021-2-27, 2022-1-26, 2022-1-27",
      "more_code_info": ""
    }
  ]
}