Events

Recall of Engstrom Ventilator & Aespire View, Aisys and Avance Anaesthesia MachinesManufactured from 23 April 2013 to 22 July 2013

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-00953-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00953-1
  • 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 involving unresponsive buttons on the display of the engstrom ventilator and the aespire view, aisys and avance anaesthesia machines. as a result of a manufacturing issue, the buttons on the left, right and bottom keypads may not always detect button presses. this may result in the inability to access certain menu functions which could possibly lead to delay in treatment.
  • Action
    The user may notice that a button press may not actuate the desired function. Usually by pressing the key again, the device will respond as expected. If a button has no response, the menu function may be accessible through the use of the control wheel. If none of the above steps can be performed, discontinue use and contact a GE Healthcare Service Representative. GE Healthcare will correct all affected systems.

Device

Engstrom Ventilator & Aespire View, Aisys and Avance Anaesthesia MachinesManufactured from 23 Apr...
  • Model / Serial
    Engstrom Ventilator & Aespire View, Aisys and Avance Anaesthesia MachinesManufactured from 23 April 2013 to 22 July 2013Multiple serial numbers affectedARTG Number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd