{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "35594",
      "product_res_number": "Z-0176-05",
      "event_date_initiated": "2004-10-21",
      "event_date_posted": "2004-11-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-11-14",
      "res_event_number": "30273",
      "product_code": "LWS",
      "pma_numbers": [
        "P980049/S3",
        "P980049/S6"
      ],
      "product_description": "Alto  implantable cardioverter defibrillator",
      "code_info": "Model Numbers DR model 614, VR model 615",
      "firm_fei_number": "2182863",
      "recalling_firm": "ela Medical Llc",
      "address_1": "2950 Xenium Ln N Ste 120 2950 Xenium Ln N",
      "address_2": "Ste 120",
      "city": "Plymouth",
      "state": "MN",
      "postal_code": "55441-2623",
      "reason_for_recall": "Alto Implantable Defibrillators Models 614 and 615.  These models can experience sudden no output, and early end of life characteristics due to metal migration in their controlling hybrids, causing high current drain leading to premature battery depletion.",
      "root_cause_description": "Other",
      "action": "The company observed occurrences of premature battery depletion and/or prolonged charge time for some Alto 614 and Alto 615 devices.  The firm is requesting physician's assistance to monitor the performance of a limited number of implanted Alto 614 and 615 devices.",
      "product_quantity": "434 users recived the product",
      "distribution_pattern": "Nationwide.\nDevices were received from the manufacturer in France.  After received in the US, No devices were distributed from the US to foreign consignees.  95 physicians received the recalled product.  \nELA Medical has contacted physicians who follow patients implanted with the devices that are the subject of the correction.  It should be noted that in many cases, the physician following the patient is not the physician who implanted the device.  Because ELA is requesting assistance to monitor the performance of implanted devices, this notification is directed at the physicians who are following the patients.",
      "openfda": {
        "pma_number": [
          "P010031",
          "P900061",
          "P980016",
          "P880086",
          "P940008",
          "P030035",
          "P970024",
          "P980050",
          "P010012",
          "P830060",
          "P970013",
          "P110042",
          "P030054",
          "P930035",
          "P910023",
          "P910073",
          "P890061",
          "P910077",
          "P880006",
          "P980049",
          "P050023",
          "P950022",
          "P960040",
          "P920015",
          "P980023",
          "P940024",
          "P220012"
        ],
        "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3015453963",
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          "2032521",
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        "fei_number": [
          "3005700659",
          "3015453963",
          "3003574398",
          "3002618605",
          "2011171",
          "3008159616",
          "1000121056",
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          "3018094310",
          "3013288201",
          "3001451463",
          "3003932293",
          "3003120897",
          "2017865",
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          "3013500228",
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          "3006705815",
          "3004105270",
          "2124215",
          "3002807576",
          "2649622",
          "2183787",
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          "3000203466",
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          "3015544746",
          "3008973940",
          "2183744",
          "3004369318",
          "1028232",
          "3013596024",
          "3012552532",
          "1828132",
          "3002806500",
          "3004961578",
          "3010273872",
          "3000215273",
          "3000206435",
          "3002806603",
          "2022502",
          "3002807561",
          "3002807314",
          "3004593495",
          "3033257494",
          "3009380063",
          "3013674629",
          "3008377825",
          "3011120183",
          "1000165971"
        ]
      }
    }
  ]
}