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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00391-1
Product Name/Description	Astral Ventilators Astral 100 Model No: 27081 Astral 150 Model No: 27083 ARTG Number: 219429
Recall Action Level	Consumer
Recall Action Classification	Class I
Recall Action Commencement Date	12/05/2015
Responsible Entity	Resmed Limited
Reason/Issue	ResMed received an incident report involving circuit disconnection of a patient in a hospital where the device alarms did not operate because all alarms had been disengaged by the physician and the patient required medical intervention.
Recall Action	Recall for Product Correction
Recall Action Instructions	ResMed advises that, as long as the disconnection alarm is not disabled for high-dependency patients who are using the device continuously, as directed in the Instructions for Use, the above safety concern will not occur. Alarm configurations can only be changed by health professionals and cannot be modified by the patient in the home. ResMed intends to release and install an updated version of Astral software, in three months’ time, in which the circuit disconnection alarm for all ventilation modes for dependent patients cannot be deactivated. For more details, please see https://www.tga.gov.au/alert/astral-100-and-astral-150-ventilators. This action has been closed-out on 05/09/2016.
Contact Information	02 8884 1000 - ResMed Ltd