Events

Recall of Carbon dioxide absorbent canister for use with the Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 anaesthesia systems

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-00459-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00459-1
  • 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 determined that the reusable carbon dioxide absorbent canisters from the affected lot may have an undersized groove which does not allow the canister to seal properly resulting in leakage of breathing system gases.
  • Action
    End users are requested to cease using the carbon dioxide absorbent canister component of their anaesthesia system. Unaffected replacement canisters will be provided by GE Healthcare.

Device

Carbon dioxide absorbent canister for use with the Aespire, Aespire View, Avance, Avance CS2, Ais...
  • Model / Serial
    Carbon dioxide absorbent canister for use with the Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 anaesthesia systemsPart Numbers: 1407-3200-000, 1407-7004-000 & M1084850Date Code: 02-2013 (Feb 2013). ARTG number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd