Events

Recall of Rotating IV Pole, used with Giraffe OmniBed Carestation, Giraffe Incubator Carestation Giraffe OmniBed, Giraffe Warmer, Panda Warmer, Giraffe Incubator, Care Plus Incubator, IWS, and Giraffe Shuttle.

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-2017-RN-01512-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01512-1
  • 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
    Ge healthcare has recently become aware of the potential for the rotating iv pole to fall. a fall could result in an injury to a bystander holding the patient or to the operator.There have been no reported injuries as a result of this issue.
  • Action
    GE Healthcare is advising hospitals to discontinue use of the affected Rotating IV poles and remove from service. Place affected Rotating IV poles in a quarantine marked area. A GE Service Representative will contact customers to arrange for the removal & replacement of a new IV pole.

Device

Rotating IV Pole, used with Giraffe OmniBed Carestation, Giraffe Incubator Carestation Giraffe Om...
  • Model / Serial
    Rotating IV Pole, used with Giraffe OmniBed Carestation, Giraffe Incubator Carestation Giraffe OmniBed, Giraffe Warmer, Panda Warmer, Giraffe Incubator, Care Plus Incubator, IWS, and Giraffe Shuttle.Part Number: 6600-0851-800Multiple Affected Lot NumbersARTG Number: 168674, 139289
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd