{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "cfres_id": "209895",
      "product_res_number": "Z-0048-2025",
      "event_date_initiated": "2024-09-03",
      "event_date_posted": "2024-10-17",
      "recall_status": "Open, Classified",
      "res_event_number": "95282",
      "product_code": "FMZ",
      "k_numbers": [
        "K152814",
        "K213551"
      ],
      "product_description": "GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator",
      "code_info": "All models",
      "firm_fei_number": "3014220748",
      "recalling_firm": "DATEX--OHMEDA, INC.",
      "address_1": "9900 W Innovation Dr",
      "city": "Wauwatosa",
      "state": "WI",
      "postal_code": "53226-4856",
      "reason_for_recall": "GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.",
      "root_cause_description": "Use error",
      "action": "GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/03/2024 via Fed-Ex.  The notice explained the problem with the device, safety issue, and requested the following:  \nDownload the Service Manual Addendum (5971733) from the GE HealthCare Customer\nDocumentation Portal:  https://www.gehealthcare.com/support/manuals.  \nInspect the heater door mounting screw on your device.  If the screw is not appropriately tightened, complete steps 9 and 10 of Section 1.1 of the Service Manual Addendum (5971733).",
      "distribution_pattern": "Worldwide distribution.",
      "openfda": {
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        ],
        "device_name": "Incubator, Neonatal",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5400",
        "device_class": "2",
        "registration_number": [
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