{
  "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": "72753",
      "product_res_number": "Z-0305-2009",
      "event_date_initiated": "2008-06-20",
      "event_date_posted": "2008-11-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-03-24",
      "res_event_number": "49097",
      "product_code": "FMZ",
      "product_description": "Giraffe OmniBed, labeled in part:   ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***.\n\nThe OmniBed is a combination of an infant incubator and an infant warmer.  The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand.",
      "code_info": "All lots.",
      "firm_fei_number": "1121732",
      "recalling_firm": "Datex Ohmeda, Inc.  dba GE Healthcare",
      "address_1": "8880 Gorman Rd",
      "city": "Laurel",
      "state": "MD",
      "postal_code": "20723-5800",
      "additional_info_contact": "Ann M. Lebar\n410-888-5200",
      "reason_for_recall": "Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.",
      "root_cause_description": "Equipment maintenance",
      "action": "A notification letter (Urgent Medical Device Correction) was sent to consignees on 06/20/08. The notification letter addressed healthcare professionals, including neonatal, infection control and nursing departments at medical facilities.  In add tion, the letter advised of revisions to the current Giraffe OmniBed cleaning instructions contained in the product Operators Manual. Instructions were enclosed with the notification letter and are intended to supplement those already present in the manual.\n\nContact the GE Healthcare Technical Support center at 1-800-558-7044 for questions or additional information.  If outside of the USA, please contact your local GE Healthcare Service Representative.",
      "product_quantity": "7,878 beds",
      "distribution_pattern": "Worldwide Distribution:  The devices were widely distributed to national and international medical facilities.",
      "openfda": {
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        "device_name": "Incubator, Neonatal",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5400",
        "device_class": "2",
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