{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "166517",
      "product_res_number": "Z-2958-2018",
      "event_date_initiated": "2018-07-26",
      "event_date_created": "2018-08-30",
      "recall_status": "Open, Classified",
      "res_event_number": "80804",
      "product_code": "OLW",
      "k_numbers": [
        "K072286"
      ],
      "product_description": "Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems.\nProduct Number/CFN: 186-0208\nUDI-Device Identifier (GTIN/UPN): 10884521130319",
      "code_info": "Batteries with date code 3114 or older (Week 31 of 2014)",
      "firm_fei_number": "1219930",
      "recalling_firm": "Covidien LLC",
      "address_1": "60 Middletown Ave",
      "city": "North Haven",
      "state": "CT",
      "postal_code": "06473-3908",
      "additional_info_contact": "same\n203-492-5000",
      "reason_for_recall": "Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems",
      "root_cause_description": "Device Design",
      "action": "Medtronic U.S. consignees were notified via Federal Express or certified mail on July 26, 2018, and the letter informs customers to inspect their batteries. Batteries with date code 3114 or older (Week 31 of 2014) exceed 4 years of age and should be removed from the monitor and disposed of according to facilitys standard process. Included with this notification are stickers to be placed on BIS\" monitors when the battery pack is removed the stickers No Battery Installed should be placed on the monitors. The BIS Vista and View monitoring systems may be used without a battery pack only if connected to AC power source with emergency power backup system (Red Outlet).",
      "product_quantity": "BIS 46,961; Spare Batteries: 6,937",
      "distribution_pattern": "Nationwide\nForeign: Australia, New Zealand",
      "openfda": {
        "k_number": [
          "K030267",
          "K260880",
          "K230693",
          "K062613",
          "K051874",
          "K031694",
          "K071899",
          "K052981",
          "K012466",
          "K974496",
          "K213273",
          "K003038",
          "K260907",
          "K040183",
          "K011534",
          "K020218",
          "K050835",
          "K973596",
          "K061907",
          "K060900",
          "K150298",
          "K172890",
          "K202621",
          "K010965",
          "K052362",
          "K083063",
          "K072286",
          "K052145",
          "K001069",
          "K042315",
          "K020671",
          "K203113",
          "K963644",
          "K023459",
          "K002837",
          "K013389",
          "K033999",
          "K060997",
          "K011834",
          "K033543"
        ],
        "registration_number": [
          "3005877899",
          "3009247326",
          "3013500228",
          "3038281851",
          "3009156722",
          "3013679558",
          "9610816",
          "3008716327",
          "3000126629",
          "3008729547",
          "3007836437",
          "3012359877",
          "8022257",
          "3001570235",
          "3008657519",
          "2221819",
          "3016674095",
          "3009831876",
          "3004203820",
          "3009077524",
          "3008202779",
          "9710602",
          "3004415095",
          "3005783425",
          "3010157426",
          "3011353843",
          "3014461810",
          "3019388613",
          "3027256461",
          "3032109181",
          "1651104",
          "9610105",
          "8044004",
          "3016701404",
          "3013596024",
          "3007603826",
          "3012528160",
          "3008483389"
        ],
        "fei_number": [
          "3005877899",
          "3002737156",
          "3009247326",
          "3013500228",
          "3038281851",
          "3009156722",
          "3001227743",
          "3013679558",
          "3008716327",
          "3000126629",
          "3008729547",
          "3007836437",
          "3012359877",
          "3001570235",
          "3008657519",
          "2221819",
          "3016674095",
          "3002807167",
          "3009831876",
          "3004203820",
          "3009077524",
          "3008202779",
          "3004415095",
          "3005783425",
          "3010157426",
          "3011353843",
          "3014461810",
          "3019388613",
          "3027256461",
          "3032109181",
          "3003757840",
          "3002806783",
          "3016701404",
          "3013596024",
          "3007603826",
          "3012528160",
          "3003513129",
          "3008483389"
        ],
        "device_name": "Index-Generating Electroencephalograph Software",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.1400",
        "device_class": "2"
      }
    }
  ]
}