{
  "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": "Andover",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85571",
      "recalling_firm": "Philips North  America, LLC",
      "address_1": "3000 Minuteman Rd",
      "address_2": "N/A",
      "postal_code": "01810-1032",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distrubtion and the countries of Albania, Argentina, Australia, Austria, Bahrain,   Bangladesh, Belgium, Bolivia, Botswana, Brazil, Bulgaria,   Cambodia, Canada, Chile, China, Colombia, Congo (Democratic Republic of the), Costa Rica, C¿te D'Ivoire, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt  El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Haiti, Hong Kong, Hungary,   India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan,   Jordan, Kazakhstan, Kenya, Korea, Republic of Lao People's , Democratic Republic Latvia, Lebanon, Libya, Macao,   Macedonia, Malaysia, Maldives, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman  Pakistan, Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania  Russian Federation, Saudi Arabia, Serbia, Singapore  Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland  Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey  Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.",
      "recall_number": "Z-2134-2020",
      "product_description": "Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator    Switchless: M1741A, M1742A, M1743A, M1744A  Switched: M4741A, M4742A, M4743A, M4744A  - Product Usage: An electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop start the heartbeat during cardiopulmonary surgery.",
      "product_quantity": "21,683 Internal Paddle Sets.",
      "reason_for_recall": "Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational checks are followed. The instructions for use rely on these checks rather than specifying a maximum number of sterilization cycles to determine  when the paddles should be discarded. A damaged Internal Paddle may not be able to deliver therapy.",
      "recall_initiation_date": "20200420",
      "center_classification_date": "20200527",
      "termination_date": "20210402",
      "report_date": "20200603",
      "code_info": "All lots"
    }
  ]
}