{
  "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": "177149",
      "product_res_number": "Z-0540-2020",
      "event_date_initiated": "2019-10-11",
      "event_date_posted": "2019-12-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-08-15",
      "res_event_number": "84077",
      "product_code": "FMT",
      "k_numbers": [
        "K152809"
      ],
      "product_description": "Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer",
      "code_info": "Giraffe Incubator Carestation, Model Numbers:2082844-002-XXXXXX \n\nUpdated 6/3/2021 - All model numbers and units are affected.",
      "firm_fei_number": "2126677",
      "recalling_firm": "GE Healthcare, LLC",
      "address_1": "3000 N Grandview Blvd",
      "city": "Waukesha",
      "state": "WI",
      "postal_code": "53188-1615",
      "additional_info_contact": "GE Healthcare Service\n800-437-1171",
      "reason_for_recall": "Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation  Bedside panels and portholes can appear closed without being latched.  Potential patient fall.",
      "root_cause_description": "Device Design",
      "action": "The firm disseminated its notices by letter beginning on 10/11/2019.  The notices identified the following safety issues:\n  - The bedside panels of Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation can be upright and look closed but not be latched.\n - The portholes also can look closed when not latched.\n - If a canopy cover is used, it can hold the bedside panel or porthole door closed without being latched.\n\nThe product may continue to be used following specific safety instructions outlined in the notice.\n\nOn/about 11/8/2019, the firm issued an \"Amended - Urgent Medical Device Recall\" letter that supplemented the previous notification to provide additional safety instructions and materials (poster regarding risk of patient fall, user manual addendum, and labeling, including safety labels).\n\nUpdate 6/3/2021: In the event a new consignee was identified, GE Healthcare has sent the original letter.",
      "product_quantity": "3467 units",
      "distribution_pattern": "worldwide",
      "openfda": {
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          "K853794",
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        "registration_number": [
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        "fei_number": [
          "3030733800",
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          "1000058335",
          "3012086037",
          "3003190524"
        ],
        "device_name": "Warmer, Infant Radiant",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5130",
        "device_class": "2"
      }
    }
  ]
}