{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "156581",
      "product_res_number": "Z-0210-2018",
      "event_date_initiated": "2017-06-14",
      "event_date_created": "2017-12-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-01-11",
      "res_event_number": "77575",
      "product_code": "LPB",
      "pma_numbers": [
        "P990071S017"
      ],
      "product_description": "SMARTABLATE RF System Generator",
      "code_info": "Product Codes M490006, M490007",
      "firm_fei_number": "3003113629",
      "recalling_firm": "Biosense Webster, Inc.",
      "address_1": "15715 Arrow Hwy",
      "city": "Irwindale",
      "state": "CA",
      "postal_code": "91706-2006",
      "reason_for_recall": "Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.",
      "root_cause_description": "Labeling design",
      "action": "All new U.S. and OUS customers, who have purchased the SMARTABLATE\" Generator system since the launch of the original field action in March 2015 to the time the IFU was updated in November 2015, will be notified. The previously distributed Field Safety Notification Letter for the SMARTABLATE\" Generator (Part Numbers# M490006 and M490007) and customer Acknowledgement Form will be sent to these new customers.  \n\nInstructions included review the Field Safety Notice carefully, provide the notice to appropriate personnel in facility, ensure the SMARTABLATE System Foot Pedal is not located within the Stereotaxis RMT Lab, complete and return the Acknowledgement Forms, and maintain awareness of the notice.",
      "product_quantity": "185 units total",
      "distribution_pattern": "Distributed to the following states: CA, CO,  GA, IL, IN, MI, NM, NY,  OH, PA, TN, TX, UT, WA, WI.  \n\nProduct was also distributed to the following countries: Germany, France, Austria, Sweden Italy, Belgium, Denmark, and Singapore.",
      "openfda": {
        "pma_number": [
          "P040036",
          "P020045",
          "P110016",
          "P950005",
          "P960016",
          "P240014",
          "P020025",
          "P030031",
          "P060019",
          "P930029",
          "P990054",
          "P000020",
          "P980003",
          "P050029",
          "P990025",
          "P920047",
          "P990071",
          "P040014"
        ],
        "registration_number": [
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        "fei_number": [
          "3044156918",
          "3008452825",
          "3019807891",
          "3002807095",
          "1000121056",
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          "3012179728",
          "3002807850",
          "3003248396",
          "3004859241",
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          "1000064530",
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          "2182269",
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          "3009243923",
          "3002808445",
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          "3013403214",
          "1450662",
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          "3003923762",
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          "3010705768",
          "3003058448",
          "3007029079",
          "3013300026",
          "3012552532",
          "3005700659"
        ],
        "device_name": "Cardiac Ablation Percutaneous Catheter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}