{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "194130",
      "product_res_number": "Z-1306-2022",
      "event_date_initiated": "2022-05-31",
      "event_date_created": "2022-06-30",
      "recall_status": "Open, Classified",
      "res_event_number": "90322",
      "product_code": "ILQ",
      "product_description": "NaviCare Nurse Call/Voalte Nurse Call",
      "code_info": "software versions: 3.9.100, 3.9.101,3.9.102, 3.9.200, 3.9.201, and 3.9.300",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "additional_info_contact": "Center for One Baxter\n800-422-9837",
      "reason_for_recall": "An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls placed from a push button call device, such as a push button switch, call cord, or from the push buttons on a room audio station, will be canceled on the nurse call system when the call is answered at the wireless phone, regardless of the call priority.",
      "root_cause_description": "Software Design Change",
      "action": "The firm disseminated an Urgent Medical Device Correction Notice beginning on 05/31/2022 by letter.  The letter described the problem and requested the following actions be taken by the customer:  \"Identify if your Nurse Call System utilizes one of the impacted wireless integrations identified. If so, please share the information with potential users in your organization.  Hillrom recommends reviewing the wireless system settings with your wireless provider\nto determine if there are configurable options for call acceptance only.\nComplete the enclosed response form and return to\nhillromCARY021@sedgwick.com within two weeks of receipt of this notice, to confirm\nyou have received this communication and understand the potential issue.\"  \nPersons with questions were directed as follows:  \"If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support, available twenty-four hours a day, seven days a week, at 1-800-445-3720, option 3, or hrccwssupport@hillrom.com\"",
      "product_quantity": "283 installations",
      "distribution_pattern": "nationwide and Canada",
      "openfda": {
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          "K771825",
          "K831093",
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          "K935244",
          "K802687",
          "K841528",
          "K925387",
          "K903605",
          "K162817",
          "K924013"
        ],
        "registration_number": [
          "3015437214",
          "3007307590",
          "3010409478",
          "3007275470",
          "1000125358",
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        "fei_number": [
          "3015437214",
          "3007307590",
          "3010409478",
          "3007275470",
          "1000125358",
          "2026803",
          "3010209365",
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          "3012616510",
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          "3006789226",
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          "3010819851",
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          "1000123308",
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          "3009869586",
          "3000126629",
          "3014653127",
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          "3005627440",
          "1000123978",
          "3029869534",
          "3012964269",
          "1000136418",
          "3000210521"
        ],
        "device_name": "System, Communication, Powered",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.3710",
        "device_class": "2"
      }
    }
  ]
}