Events

Recall of Avance, Amingo, Aisys Anaesthesia Devices (software version 8.00) and Avance CS Anaesthesia Devices (with software version 10.00)

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-01039-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01039-1
  • 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
    While operating in pressure control ventilation - volume guarantee (pcv-vg) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). exposure to excessive tidal volumes while pressure limits are maintained can result in pulmonary volutrauma and/or an increased pulmonary vascular resistance that can negatively affect cardiac filling pressure and/or stroke volume.
  • Action
    GE Healthcare is providing users with work around instructions to follow until a software upgrade is provided to all customers by June 2014.

Device

Avance, Amingo, Aisys Anaesthesia Devices (software version 8.00) and Avance CS Anaesthesia Devic...

Manufacturer

GE Healthcare Australia Pty Ltd