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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00038-1
Product Name/Description	Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, and Avance CS2 Anesthesia devices installed from April 20, 2015 through October 2015. Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affected Service kit part numbers: 1009-8216-000, 1503-3006-000, 1503-8102-000, 1009-8423-000 and 1503-8101-000 ARTG Number: 93955
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	12/01/2016
Responsible Entity	GE Healthcare Australia Pty Ltd
Reason/Issue	The Drive Gas Check Valve of the affected devices could become stuck in a fixed open position which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma. There have been no injuries reported as a result of this issue.
Recall Action	Recall for Product Correction
Recall Action Instructions	The sponsor is advising users that the affected devices can continue to be used. In the event the reported issue does occur, the affected device provides alarms and there are automatic inherent safety mitigations by design to help ensure patient safety. The sponsor will contact users to arrange for an on-site correction. This action has been closed-out on 03/02/2017.
Contact Information	1800 659 465 - GE National Call Centre