{
  "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": "86314",
      "product_res_number": "Z-0420-2010",
      "event_date_initiated": "2009-10-01",
      "event_date_posted": "2009-11-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-09-22",
      "res_event_number": "53681",
      "product_code": "LBI",
      "k_numbers": [
        "K022196"
      ],
      "product_description": "The Natus Blue Light Phototherapy is also called the \"neoBLUE LED Phototherapy System\".  The \"neoBLUE mini LED Phototherapy System\"",
      "code_info": "Catalogue / Part Numbers: 010101 (110V, US, new); 010101R (110V, US, refurbish); 010102 (230V, UK, new); 010102R (230V, UK, refurbish); 010103 (230V, EUR, new); 010103R (230V, EUR, refurbish); 010104 (230V, EUR, new); 010104R (230V, EUR, refurbish).  AFFECTED SERIAL NUMBERS:   60011-60013, 60015, 60017, 60021-60029, 60031-60033, 60035, 60037, 60038, 60101-60120, 60124-60128, 60131-60324, 60327-60349, 60351-60403, 60405, 60407-60415, 60417-60507, 60509-60586, 60588-60606, 60608-60611, 60613-60845, 60847-61000, 61002-61293, 61295-61340, 61346-61574, 61577-61590, 62001-62026, 62028-62032, 62035-62145, 62147-62163, 62165-62245, 62247-62252, 62254-62309, 62311-62350, 62352-62433, 62435-62481, 62485-62634, 62636-62640, and 62642-62656.",
      "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": "206-767-3500",
      "reason_for_recall": "The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp.  No injuries have been reported.",
      "root_cause_description": "Device Design",
      "action": "On 10/1/09 Natus notified domestic consignees by Urgent Product Advisory Notice letter that advised them of the issue, instructed them to inspect the clamps, and included pictures of the affected clamp.  Consignees are instructed to return the recalled clamps for a new replacement to be shipped by Natus.\nInternational distribution partners were notified by letter on 10/1/2009 and instructed to identify and contact their consignees.  Replacements will be sent to the distribution partner for their consignees.",
      "product_quantity": "2127",
      "distribution_pattern": "Worldwide distribution: USA, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Chile, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Portugal, PR, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, and UK",
      "openfda": {
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          "K883779",
          "K901987",
          "K070180",
          "K884133",
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          "K940996",
          "K142332",
          "K984589",
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          "K093618",
          "K103828",
          "K111547",
          "K022196",
          "K113206",
          "K931965",
          "K210289",
          "K040853",
          "K954611",
          "K090192",
          "K840454",
          "K103735",
          "K002414",
          "K160305",
          "K850599",
          "K182178",
          "K243372",
          "K813188",
          "K962612",
          "K802702",
          "K971601",
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          "K912908",
          "K051869",
          "K053568",
          "K103589",
          "K170585",
          "K251308",
          "K021531",
          "K832298",
          "K991627",
          "K894129"
        ],
        "registration_number": [
          "1000312377",
          "3002807523",
          "3012348048",
          "3000279201",
          "3014128880",
          "1000617661",
          "3014220748",
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        "fei_number": [
          "1000312377",
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          "3010611950",
          "3000957797",
          "3002806988",
          "1000058335",
          "1000122810",
          "3003190524"
        ],
        "device_name": "Unit, Neonatal Phototherapy",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5700",
        "device_class": "2"
      }
    }
  ]
}