{
  "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": "141675",
      "product_res_number": "Z-0457-2016",
      "event_date_initiated": "2015-10-28",
      "event_date_posted": "2015-12-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-02-15",
      "res_event_number": "72619",
      "product_code": "DRL",
      "k_numbers": [
        "K110192"
      ],
      "product_description": "DA-2006P - Defibrillator / Pacer Analyzer;\n\nProduct Usage:\nIntended to measure the output of a defibrillator or transcutaneous pacemaker.",
      "code_info": "SN:  73962222, 73962223, 73962224, 73962225, and 73962226",
      "firm_fei_number": "2939012",
      "recalling_firm": "BC Group International Inc",
      "address_1": "3081 Elm Point Industrial Dr",
      "city": "Saint Charles",
      "state": "MO",
      "postal_code": "63301-4333",
      "additional_info_contact": "Melvin L. Roche, Jr.\n314-638-3800",
      "reason_for_recall": "Device is not functioning as intended:  Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.",
      "root_cause_description": "Employee error",
      "action": "The recalling firm issued return authorization numbers to the two customers who submitted complaints regarding the malfunctioning device. The customers sent back the units and the recalling firm replaced their devices with new units. On 10/29/2015, the recalling firm contacted their third customer by phone and informed them that the three devices they had in their possession were miswired which would cause the inverted ECG waveform. The recalling firm issued a return authorization number to their customer for the three devices. The recalling firm told their customer they would repair the devices and return them.",
      "product_quantity": "5 units",
      "distribution_pattern": "US Nationwide Distribution in the states of South Carolina, Florida, and Canada.",
      "openfda": {
        "k_number": [
          "K961595",
          "K963190",
          "K790394",
          "K083347",
          "K880780",
          "K030547",
          "K782033",
          "K072114",
          "K895525",
          "K934254",
          "K182905",
          "K941404",
          "K904159",
          "K062099",
          "K190437",
          "K896985",
          "K153210",
          "K110192",
          "K954391"
        ],
        "registration_number": [
          "2921581",
          "9615335",
          "2939012",
          "2436826"
        ],
        "fei_number": [
          "3002806858",
          "2921581",
          "2939012",
          "1000522032"
        ],
        "device_name": "Tester, Defibrillator",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5325",
        "device_class": "2"
      }
    }
  ]
}