Events

Recall of Avance CS2, Avance, and Amingo anaesthesia devices with the optional large tray insert accessory installed

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-2016-RN-01406-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01406-1
  • 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 become aware of a potential safety issue where certain avance cs2, avance and amingo anaesthesia devices can transition to a system malfunction state if the lower storage drawer containing the optional large tray insert accessory, is closed with an abnormally high amount of force. should the anaesthesia device transition to a system malfunction state the device will perform in the following manner:- automatically activate alternate oxygen flow within a few seconds,- provide high priority audible and visible alarms,- provide on display instructions to set the oxygen (o2) flow and manually ventilate the patient,- continue to deliver anaesthetic agent at the existing vaporizer setting.If the system malfunction is left unresolved, it could result in loss of patient ventilation potentially resulting in hypoxia. there have been no injuries reported as a result of this issue.
  • Action
    GE is advising users that they can continue to use their Avance CS2, Avance, and Amingo devices after the optional large tray insert accessory has been removed. Customers are requested to destroy all large tray inserts in their possession.However, customers should contact GE if they choose to return the tray insert. This action has been closed-out on 18/05/2017.

Device

Avance CS2, Avance, and Amingo anaesthesia devices with the optional large tray insert accessory ...
  • Model / Serial
    Avance CS2, Avance, and Amingo anaesthesia devices with the optional large tray insert accessory installed Part Number of large tray insert : 1009-3260-000ARTG Number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd