{
  "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": [
    {
      "country": "United States",
      "city": "Irwindale",
      "address_1": "15715 Arrow Hwy",
      "reason_for_recall": "Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has received two complaints reporting that during an RMT procedure the SMARTABLATE RF Generator inadvertently delivered RF energy.",
      "address_2": "",
      "product_quantity": "115 units",
      "code_info": "SMARTABLATE System Serial No. G4C-0296, G4C-0297, G4C-0272, G4C-0262, G4C-0232, G4C-0090.    System Serial No. G4C-0076, G4C-0195, G4C-0064, G4C-0047, G4C-0159, G4C-0187, G4C-0146, G4C-0140, G4C-0037, G4C-0131, G4C-0031, G0054.",
      "center_classification_date": "20150528",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the state of:  CA, IL, KY, NJ, PA and the countries of: Czech Republic, Denmark, Finland, France, Germany, and Sweden.",
      "state": "CA",
      "product_description": "SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107.    Product Usage:  The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is designed to initiate or discontinue operation of the SMARTABLATE System. The Foot Pedal can be connected to the SMARTABLATE RF Generator, SMARTABLATE Irrigation Pump; or SMARTABLATE Remote Control.",
      "report_date": "20150603",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Biosense Webster, Inc.",
      "recall_number": "Z-1691-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "70772",
      "termination_date": "20150617",
      "more_code_info": "",
      "recall_initiation_date": "20150319",
      "postal_code": "91706-2006",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}