Events

Recall of Device Recall GE Healthcare/Ohmeda Medical Giraffe OmniBed.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Datex Ohmeda, Inc. dba GE Healthcare.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49097
  • Event Risk Class
    Class 2
  • Event Number
    Z-0305-2009
  • Event Initiated Date
    2008-06-20
  • Event Date Posted
    2008-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72753
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Neonatal lncubator. - Product Code FMZ
  • Reason
    Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.
  • 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. Contact 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.

Device

Device Recall GE Healthcare/Ohmeda Medical Giraffe OmniBed.
  • Model / Serial
    All lots.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: The devices were widely distributed to national and international medical facilities.
  • Product Description
    Giraffe OmniBed¿, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. || The 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.
  • Manufacturer
    Datex Ohmeda, Inc. dba GE Healthcare

Manufacturer

Datex Ohmeda, Inc. dba GE Healthcare
  • Manufacturer Address
    Datex Ohmeda, Inc. dba GE Healthcare, 8880 Gorman Rd, Laurel MD 20723-5800
  • Source
    USFDA