Events

Recall of Giraffe Incubator and Giraffe OmniBed with Servo Oxygen Control SystemManufactured between August 1 2012 and December 20 2012

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare Australia Pty Ltd.

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
    RC-2013-RN-00023-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-01-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00023-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    When the giraffe omnibed and giraffe incubator is powered "on" or there is a recovery from power failure, the oxygen set point or radiant heater set point (values that are entered by the clinician) may be overwritten due to a potential overwriting of stored information associated with the display printed circuit board.
  • Action
    GE Healthcare is advising hospitals may continue to use the affect product, however, all set points must be confirmed when powering 'on' the Giraffe microenvironment or when recovering from a power failure event. A software update will be provided by GE Healthcare to correct the issue.

Device

Giraffe Incubator and Giraffe OmniBed with Servo Oxygen Control SystemManufactured between August...

Manufacturer

GE Healthcare Australia Pty Ltd