Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00459-1
Product Name/Description Carbon dioxide absorbent canister for use with the Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 anaesthesia systems

Part Numbers: 1407-3200-000, 1407-7004-000 & M1084850

Date Code: 02-2013 (Feb 2013).

ARTG number: 93955
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 16/05/2013
Responsible Entity GE Healthcare Australia Pty Ltd
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.
Contact Information 1300 722 229 - GE Healthcare National Service and Support Centre