{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Ann Arbor",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65085",
      "recalling_firm": "Heart Sync, Inc",
      "address_1": "5643 Plymouth Rd",
      "address_2": "N/A",
      "postal_code": "48105-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA,  and Internationally to Korea.",
      "recall_number": "Z-1434-2013",
      "product_description": "Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes    Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.",
      "product_quantity": "17180 units for all part numbers",
      "reason_for_recall": "On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.",
      "recall_initiation_date": "20130426",
      "center_classification_date": "20130530",
      "termination_date": "20140416",
      "report_date": "20130605",
      "code_info": "Part number : C100-Physio and Lot numbers: Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01"
    }
  ]
}