{
  "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": "148064",
      "product_res_number": "Z-0056-2017",
      "event_date_initiated": "2016-08-25",
      "event_date_posted": "2016-10-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-03-07",
      "res_event_number": "74627",
      "product_code": "FMZ",
      "k_numbers": [
        "K070291"
      ],
      "product_description": "The Medix NatalCare LX Intensive Care Incubator.  Neonatal incubator.\nItem numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.",
      "code_info": "5045, 5046, 5047, 5048, 5051, 5053, 5056, 5057, 5096, 5097, 5128, 5129, 5130, 5131, 5132, 5133, 5134, 5135, 5136, 5138, 5139, 5209, 5210, 5211, 5212, 5213, 5214, 5219, 5220, 5221, 5222, 5223, 5224, 5225, 5226, 5227, 5228, 5248, 5249, 5250, 5251, 5252, 5253, 5254, 5255, 5256, 5257, 5276, 5277, 5278, 5279, 5280, 5281, 5282, 5283, 5284, 5285, 5286, 5287, 5288, 5289, 8290, 5291, 5292, 5293, 5294, 5322, 5323, 5324, 5325, 5326, 5327, 5328, 5329, 5330, 5331, 5332, 5333, 5334, 5335, 5336, 5337, 5383, 5385, 5388, 5389, 5504, 5505, 5506, 5507, 5508, 5509, 5510, 5511, 5543, 5544, 5545, 5546, 5547, 5548, 5549, 5550, 5551, and 5552.",
      "firm_fei_number": "3018859",
      "recalling_firm": "Natus Medical Incorporated",
      "address_1": "5900 1st Ave S",
      "city": "Seattle",
      "state": "WA",
      "postal_code": "98108-3248",
      "additional_info_contact": "888-496-2887",
      "reason_for_recall": "NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate.  There were several complaints of wheels bending out of alignment.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "Natus sent an Urgent Notification Field Safety Notice on August 25, 2016 to all affected customers. \n\nCustomers are asked to inspect the quality of the welds and wheel alignment for the Natal Care LX Incubators at their facility per attached Inspection Instructions for Assessing the Natal Care LX Wheeled-Based Joint and Weld.\n\nCustomers  are provided with the Natal Care LX Rolling Base Verification Form (DOC-019727) and are requested to verify the weld and gap status for each of the four wheels on the incubator and to note the results on the verification form.  After the Verification form is completed and returned to Natus, Natus will arrange to ship a repair kit for each affected wheel, along with instructions and simple tools to facilitate the repair of the Natal Care LX base.\n\nNatus Technical Service will follow-up with phone calls to all non-responding customers and again to verify that the repairs have been performed.\n\nConsignees who have any questions, please call Technical Service at 888-496-2887 or send email to technical_service@natus.com",
      "product_quantity": "104 units",
      "distribution_pattern": "US Distribution to the states of : AL, CA, FL, IL, IN, KY, LA, MA, MS, NJ, NY, OK, PA, SC and VA,  and Internationally to Pakistan.",
      "openfda": {
        "k_number": [
          "K813239",
          "K900735",
          "K813238",
          "K802639",
          "K822656",
          "K801461",
          "K924170",
          "K251619",
          "K040910",
          "K101778",
          "K003067",
          "K954204",
          "K903378",
          "K781876",
          "K943360",
          "K920049",
          "K053399",
          "K974349",
          "K101788",
          "K912000",
          "K132543",
          "K832418",
          "K962806",
          "K182859",
          "K914487",
          "K912910",
          "K901585",
          "K884086",
          "K061280",
          "K912909",
          "K260326",
          "K871399",
          "K070291",
          "K993712",
          "K102226",
          "K840526",
          "K182977",
          "K901157",
          "K914134",
          "K102279",
          "K213553",
          "K071175",
          "K243437",
          "K922618",
          "K190494",
          "K881476",
          "K895550",
          "K940975",
          "K924297",
          "K020547",
          "K870223",
          "K900752",
          "K915752",
          "K870222",
          "K172154",
          "K152809",
          "K040068",
          "K821896",
          "K102710",
          "K031387",
          "K010222",
          "K152814",
          "K251663",
          "K061856",
          "K924324",
          "K162821",
          "K890476",
          "K071977",
          "K780472",
          "K020543",
          "K960980",
          "K021809",
          "K914864",
          "K810067",
          "K895782",
          "K001242",
          "K810792",
          "K913154",
          "K993407",
          "K802126",
          "K913291",
          "K993051",
          "K913394",
          "K802640",
          "K980886",
          "K072512"
        ],
        "device_name": "Incubator, Neonatal",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5400",
        "device_class": "2",
        "registration_number": [
          "",
          "3012348048",
          "9611500",
          "1055236",
          "3001104093",
          "3021559257",
          "1000122786",
          "1054713",
          "3007734888",
          "1054241",
          "3030089838",
          "3009077524",
          "1066270",
          "1034876",
          "9613793",
          "1226711",
          "3006179052",
          "3008729547",
          "3005934741",
          "3014220748",
          "1043214",
          "3005652389",
          "3036470679",
          "9710602",
          "2510954"
        ],
        "fei_number": [
          "",
          "3012348048",
          "3001104093",
          "3021559257",
          "1000122786",
          "3007734888",
          "1000114111",
          "3030089838",
          "3009077524",
          "3023530182",
          "3003338236",
          "3004846435",
          "1034876",
          "3006179052",
          "3008729547",
          "3005934741",
          "3014220748",
          "3000957797",
          "1043214",
          "1000112877",
          "3003513129",
          "3036470679",
          "2510954",
          "1000112968",
          "3006469671"
        ]
      }
    }
  ]
}