{
  "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": "210892",
      "product_res_number": "Z-0570-2025",
      "event_date_initiated": "2024-11-01",
      "event_date_posted": "2024-11-27",
      "recall_status": "Open, Classified",
      "res_event_number": "95652",
      "product_code": "IQA",
      "product_description": "Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application",
      "code_info": "All Systems using Arial Server Software versions 11.1.4 through 11.1.6 in conjunction with the Arial Mobile Application or Arial Care Giver Application",
      "firm_fei_number": "1929691",
      "recalling_firm": "Securitas Healthcare LLC",
      "address_1": "4600 Vine St",
      "city": "Lincoln",
      "state": "NE",
      "postal_code": "68503-2823",
      "additional_info_contact": "Ameya Oke\n402-475-4002",
      "reason_for_recall": "Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.",
      "root_cause_description": "Software Design Change",
      "action": "An URGENT: MEDICAL DEVICE CORRECTION letter dated 10/31/24 was sent to customers.\n\nNecessary Actions to be Taken by Clients\nInstructions for determining which versions of the Arial Server Software you are using are attached hereto as Exhibit C. Clients using Arial Server Software versions 11.1.4.9, 11.1.5.5, or 11.1.6.2 should:\n1. Not  decline  previously cleared calls through the Arial App;\n2. Restart the Arial Server Software if an end user has  declined  a previously  completed \ncall using the Arial App. After restarting the Arial Server Software, calls from the affected\ncall point(s) will begin to be received by the Arial Server Software and the Arial Server\nSoftware will notify end users as intended. Instructions for restarting the Arial Server\nSoftware are included on Exhibit B.\n3. Contact Securitas Healthcare Technical Support at 1 (800) 380-8883 to upgrade the Arial\nServer Software to version 11.1.7 or later.\n\nFor general questions concerning this communication please contact Securitas Healthcare\nTechnical Support at 1 (800) 380-8883.\n\nWe ask that you please complete and return a copy of the acknowledgement form attached hereto as Exhibit A.",
      "product_quantity": "111 systems",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Switzerland.",
      "openfda": {
        "k_number": [
          "K953905",
          "K850314",
          "K840808",
          "K940223",
          "K961306",
          "K902664",
          "K873612",
          "K911101",
          "K851740",
          "K850313",
          "K872936",
          "K770028",
          "K944585",
          "K943244",
          "K921528",
          "K953937",
          "K881634",
          "K872937",
          "K832057",
          "K901028",
          "K890596",
          "K926029",
          "K944345",
          "K900969"
        ],
        "device_name": "System, Environmental Control, Powered",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.3725",
        "device_class": "2",
        "registration_number": [
          "3007200970",
          "3006802317",
          "3017404332",
          "3008855170",
          "3003114240",
          "3002713667",
          "3009591865",
          "3012505893",
          "3011699327",
          "3021667368",
          "3014024339",
          "1320360",
          "3013513594",
          "3008952681",
          "3001757821",
          "3006789226",
          "1929691",
          "3030181825"
        ],
        "fei_number": [
          "3007200970",
          "3006802317",
          "3017404332",
          "3008855170",
          "3003114240",
          "3002713667",
          "3009591865",
          "3012505893",
          "3011699327",
          "3021667368",
          "3014024339",
          "3013513594",
          "3008952681",
          "3001757821",
          "3006789226",
          "3000210521",
          "1929691",
          "3030181825"
        ]
      }
    }
  ]
}