{
  "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": "189999",
      "product_res_number": "Z-0402-2022",
      "event_date_initiated": "2021-10-14",
      "event_date_created": "2021-12-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-08-16",
      "res_event_number": "88909",
      "product_code": "ILQ",
      "product_description": "These are communication systems, labeled as:\na.\tNaviCare Nurse Call, Part Numbers:  3.6, 3.7, 3.9\nb.\tVoalte Nurse Call, Part Number 4.0\n\n\n*Product was rebranded from NaviCare to Voalte in 2020",
      "code_info": "All software versions 3.5.400 and above:\na.\tPart Number 3.6, UDI 00887761001541; Part Number 3.7, UDI 00887761021198; Part Number 3.9, UDI 00887761985209\nb.\tPart Number 4.0, UDI 00887761995079",
      "firm_fei_number": "2027454",
      "recalling_firm": "Hill-Rom Inc.",
      "address_1": "1225 Crescent Grn Ste 300 1225 Crescent Grn",
      "address_2": "Ste 300",
      "city": "Cary",
      "state": "NC",
      "postal_code": "27518-8119",
      "additional_info_contact": "Howard Karesh\n312-237-6188",
      "reason_for_recall": "An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The firm disseminated a Medical Device Correction Notice to its consignees on 10/21/2021 by mail. \n\nCustomer:\nPlease share the information with potential users in your organization. Complete the attached response form and return to HillromCARY007@sedgwick.com within one month of receipt of this notice to confirm you have received this communication and understand the potential issue. In the event, this issue should occur please contact Hillrom Technical Support at 1-800-445-3720, option 3 or  hrccwssupport@hillrom.com for service and replacement. Hillrom has remediated this issue as part of the next software upgrade to version 4.0.300. Please contact Hillrom to discuss software upgrade.   \n\nDistributor:\nPlease share this information with your nurse call customer base.  Complete the attached response form and return to HillromCARY007@sedgwick.com within one month of receipt of this notice to confirm you have received this communication, understand the potential issue and will take action to inform your customer base.",
      "product_quantity": "1,050 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide.",
      "openfda": {
        "k_number": [
          "K923819",
          "K924013",
          "K771825",
          "K841528",
          "K812720",
          "K770030",
          "K905474",
          "K901030",
          "K802687",
          "K902206",
          "K910796",
          "K935981",
          "K924030",
          "K924014",
          "K770031",
          "K863995",
          "K914259",
          "K905576",
          "K831093",
          "K162817",
          "K770029",
          "K910819",
          "K903605",
          "K925387",
          "K901029",
          "K904796",
          "K821677",
          "K903652",
          "K931855",
          "K925527",
          "K935244",
          "K864204",
          "K943035",
          "K893473",
          "K842535",
          "K930044",
          "K914103",
          "K924015"
        ],
        "registration_number": [
          "3012964269",
          "3013281419",
          "3018783526",
          "3014315249",
          "2950167",
          "3005627440",
          "3004959902",
          "3009869586",
          "3007729562",
          "1528659",
          "1526550",
          "3009444092",
          "1320360",
          "3006141275",
          "3009591865",
          "2026803",
          "3001576173",
          "3006789226",
          "3005301283",
          "3017237915",
          "2132111",
          "3023272766",
          "3020018",
          "1122989",
          "3008994998",
          "3014653127",
          "3007275470",
          "1000125358",
          "2027454",
          "3015437214",
          "3010409478",
          "3031563240",
          "3014663624",
          "3008243322",
          "3015185344",
          "3029869534",
          "3010209365",
          "3009879967",
          "3006891627",
          "3007883990",
          "3007728289",
          "3010824482",
          "3002713667",
          "3000126629",
          "3012616510"
        ],
        "fei_number": [
          "3012964269",
          "1000123978",
          "3013281419",
          "3018783526",
          "3014315249",
          "3005627440",
          "3004959902",
          "3009869586",
          "3007729562",
          "3009444092",
          "3006141275",
          "3009591865",
          "2026803",
          "3001576173",
          "3006789226",
          "3005301283",
          "3017237915",
          "3023272766",
          "3020018",
          "1000123308",
          "3000210521",
          "3008994998",
          "3014653127",
          "3007275470",
          "1000125358",
          "2027454",
          "3015437214",
          "3010409478",
          "3031563240",
          "3014663624",
          "1000136418",
          "3008243322",
          "3015185344",
          "3010819851",
          "3029869534",
          "3010209365",
          "3009879967",
          "1000140026",
          "3006891627",
          "3007883990",
          "3007728289",
          "3010824482",
          "3002713667",
          "3000126629",
          "3012616510"
        ],
        "device_name": "System, Communication, Powered",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.3710",
        "device_class": "2"
      }
    }
  ]
}