{
  "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": "131593",
      "product_res_number": "Z-0847-2015",
      "event_date_initiated": "2014-11-19",
      "event_date_posted": "2014-12-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-07-20",
      "res_event_number": "69820",
      "product_code": "LBI",
      "k_numbers": [
        "K022196"
      ],
      "product_description": "Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system.  Neonatal phototherapy.",
      "code_info": "All distributed Natus neoBLUE 2 systems with LED PCB replacements received after February 16, 2012.   For use only with neoBLUE devices manufactured between 2002 and 2007 (neoBLUE2)",
      "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": "Technical Service\n888-496-2887",
      "reason_for_recall": "Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device.  While some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.",
      "root_cause_description": "Other",
      "action": "Natus Medical has begun mailing  the Urgent Recall Notification/Field Safety Notice neoBLUE LED Board Replacements letter (DOC-012737B), dated November 5, 2014, to US consignees.\n\nNatus Medical  also send the Product Advisory neoBLUE LED Board Replacements letter (DOC-0012738), dated October 30, 2014, to  International Distribution Partners.\n\nBoth US and International consignees also received the TECHNICAL BULLETIN LED Board Kit, neoBLUE 2 LED Phototherapy System, p/n: 001840, Treatment Intensity with revised LED board for neoBLUE 2 systems (p/n: 040904 & 040906) [DOC 008353]; and the Label, neoBLUE Intensity/Height (DOC 011561).\n\nConsignees are instructed to measure the light intensity of their devices and to document that information of the device using an adhesive label that is provided.\n\nThe neoBLUE 3 system and its replacement panel sold today are not\naffected by this issue.  If there are any questions regarding this advisory letter or the attached Technical Bulletin, please call Natus Technical Service at 888-496-2887.",
      "product_quantity": "1907 total (1413 in US and 494 international)",
      "distribution_pattern": "worldwide",
      "openfda": {
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        "registration_number": [
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        ],
        "fei_number": [
          "1000312377",
          "3002807523",
          "3012348048",
          "3000203066",
          "3000279201",
          "3014128880",
          "1000617661",
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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"
      }
    }
  ]
}