{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "198840",
      "product_res_number": "Z-1338-2023",
      "event_date_initiated": "2023-02-20",
      "event_date_posted": "2023-04-04",
      "recall_status": "Open, Classified",
      "res_event_number": "91782",
      "product_code": "OMA",
      "k_numbers": [
        "K080217"
      ],
      "product_description": "Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements\nModel: CNS-350",
      "code_info": "UDI Number:  B485CNS3501\nSerial Numbers:\nA-CNS-22502\t\t\nA-CNS-22506\t\t\nA-CNS-22507\t\t\nA-CNS-22508\t\t\nA-CNS-22509\t\t\nA-CNS-22510\t\t\nA-CNS-22511\t\t\nA-CNS-22512\t\t\nA-CNS-22513\t\t\nA-CNS-22525\t\t\nA-CNS-22526\t\t\nA-CNS-22527\t\t\nA-CNS-22528\t\t\nA-CNS-22529\t\t\nA-CNS-22530\t\t\nA-CNS-22534\t\t\nA-CNS-22535\t\t\nA-CNS-22536\t\t\nA-CNS-22537\t\t\nA-CNS-22541\t\t\nA-CNS-22542\t\t\nA-CNS-22543\t\t\nA-CNS-22544\t\t\n\t\t\nA-CNS-22545\t\t\nA-CNS-22546\t\t\nA-CNS-22547\t\t\nA-CNS-22548\t\t\nA-CNS-22549\t\t\nA-CNS-22550\t\t\nA-CNS-22551\t\t\nA-CNS-22552\t\t\nA-CNS-22553\t\t\nA-CNS-22554\t\t\nA-CNS-22555\t\t\nA-CNS-22556\t\t\nA-CNS-22557\t\t\nA-CNS-22558\t\t\nA-CNS-22559\t\t\nA-CNS-22560\t\t\nA-CNS-22561\t\t\nA-CNS-22562\t\t\nA-CNS-22564\t\t\nA-CNS-22565\t\t\nA-CNS-22566\t\t\nA-CNS-22567\t\t\t\n\t\t\t\nA-CNS-22568\t\t\t\nA-CNS-22569\t\t\t\nA-CNS-22570\t\t\t\nA-CNS-22571\t\t\t\nA-CNS-22572\t\t\t\nA-CNS-22573\t\t\t\nA-CNS-22574\t\t\t\nA-CNS-22575\t\t\t\nA-CNS-22577\t\t\t\nA-CNS-22578\t\t\t\nA-CNS-22584\t\t\t\nA-CNS-22585\t\t\t\nA-CNS-22586\t\t\t\nA-CNS-22587\t\t\t\nA-CNS-22588\t\t\t\nA-CNS-22589\t\t\t\nA-CNS-22590\t\t\t\nA-CNS-22591",
      "firm_fei_number": "3007880955",
      "recalling_firm": "Moberg Research, Inc.",
      "address_1": "224 S Maple Way",
      "city": "Ambler",
      "state": "PA",
      "postal_code": "19002-5528",
      "additional_info_contact": "SAME\n215-283-0860",
      "reason_for_recall": "Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin.\nDOC",
      "root_cause_description": "Under Investigation by firm",
      "action": "Natus issued Letters Urgent Medical Device Recall Letter Component Neuromonitoring System (Moberg CNS Monitor Model CNS-350) via first class beginning Feb 20, 2023. Letter states reason for recall, health risk and action to take:\nEnsure that the CNS is either shut down or plugged into a power outlet. Perform the next step while using proper personal protective equipment (PPE), including gloves. On the top of the CNS-350 device, open each of the three (3) battery ports and remove any backup battery.\n 2) Inspect the battery and the battery port for any white, brown, or green/blue buildup, or for any corrosion of the metal contact locations.\na. Dispose of the battery at your local electronic e-waste facility.\nNote: The CNS-350 device may continue to be used (while plugged into a power outlet)\nwith the backup battery removed.\nb. If battery leakage or corrosion is suspected, cease use of the CNS-350 device.\n\nNew replacement battery will be shipped to you. The Moberg Technical Service department will be in contact with you in relation to the provision of the replacement product. For new battery replacement, installation instructions will be provided with the battery.",
      "product_quantity": "89 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of France, Germany, Italy, Sweden.",
      "openfda": {
        "k_number": [
          "K081551",
          "K093949",
          "K123079",
          "K983229",
          "K092573",
          "K031149",
          "K161027",
          "K120485",
          "K080217",
          "K192889",
          "K791580",
          "K071449",
          "K131789",
          "K152301",
          "K130238",
          "K163644"
        ],
        "registration_number": [
          "9612330",
          "3010611950",
          "3023164",
          "3013501110",
          "8030229",
          "3015929663",
          "2031720",
          "3005581270",
          "2080783",
          "3017374042",
          "9611252",
          "3016852448",
          "9612389"
        ],
        "fei_number": [
          "3010611950",
          "3002807720",
          "3002624053",
          "3003255845",
          "3023164",
          "3002807739",
          "3013501110",
          "3015929663",
          "3002809369",
          "3005581270",
          "2080783",
          "3017374042",
          "3016852448"
        ],
        "device_name": "Amplitude-Integrated Electroencephalograph",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.1400",
        "device_class": "2"
      }
    }
  ]
}