{
  "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": "Irwindale",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "67505",
      "recalling_firm": "Biosense Webster, Inc.",
      "address_1": "15715 Arrow Hwy",
      "address_2": "",
      "postal_code": "91706-2006",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA including CA, KY, NJ, MA, and UT and Internationally to Belgium, Austria, and Germany.",
      "recall_number": "Z-1045-2014",
      "product_description": "CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124    WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE INTEGRATED INTO THE CART0 3 SYSTEM MAP VIEWERS (MAP VIEWER AND ADDITIONAL VIEW), CART0 3 MAPS, MRl OR CT IMAGES, AND CATHETER VISUALIZATION ARE SUPERIMPOSED ON THE FLUOROSCOPIC CAPTURE.",
      "product_quantity": "8 units total (5 units in US)",
      "reason_for_recall": "Biosense Webster has initiated a recall of the  CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only.  If the table rotation is not returned to zero point, there is a misalignment between the Carto 3 System map display and the fluoroscopic capture.",
      "recall_initiation_date": "20140212",
      "center_classification_date": "20140220",
      "termination_date": "20140523",
      "report_date": "20140226",
      "code_info": "Serial No. 13201, 11125, 11519, 11320, 11115.",
      "more_code_info": ""
    }
  ]
}