Events

Recall of Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers (infant radiant warmer)

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-2012-RN-01081-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-10-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01081-1
  • 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 a potential safety issue wherein the oxygen and air wall inlet fittings and/or labels on the back panel, were reversed during assembly. as a result, this may potentially have reversed air/oxygen mixer concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. the settings of the blender knob will no longer be accurate.
  • Action
    If the affected unit is in use with a patient, GE is asking customers to disconnect the wall supply gas and switch to tank supply. If the affected unit is not currently in use, GE is asking customers to take the unit out of service. A GE Field Engineer will be deployed to the affected site to complete the required repair.

Device

Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers (infan...

Manufacturer

GE Healthcare Australia Pty Ltd