Events

Recall of All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015

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-2015-RN-01233-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-12-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01233-1
  • 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
    If the clear patient history prompt is not responded to, the previous patient's weight could be displayed on the giraffe carestation user interface.This could cause clinical decisions to be made based on the weight associated with the wrong patients, which in turn could lead to clinical decisions which could require medical intervention.There have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare is providing work around instructions for users to follow as an interim measure. A software upgrade will be provided as a permanent correction. This action has been closed-out on 29/08/2016.

Device

All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015
  • Model / Serial
    All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015Giraffe Incubator Carestation Serial Numbers: TAAU67001, TAAU67002, TAAU67003, TAAU67004, TAAU67006, TAAU67007, TAAU67011, TAAU67012Giraffe OmniBed Carestation Serial Numbers: TABU67001, TABU67002, TABU67003, TABU67005, TABU67006, TABU67007, TABU67008, TABU67009, TABU67011 ARTG Number: 139289
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd