| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00050-2 |
| Product Name/Description |
Astral Ventilators - ResMed Astral 100 & Astral 150 with SR1.1 software (SX544-0301)
Product Codes 27081 and 27083
ARTG Number: 219429 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
Astral devices may experience an issue when powered by an external battery (Astral External Battery or RPS II). The issue can prevent the user from powering on the device after the Auto power off feature powers off the device when there has been no user interaction with the device for 15 minutes and the ventilator is in stand-by.
The external battery start up issue only affects Astral 100 and Astral 150 devices with SR1.1 software (SX544-0301). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
ResMed is advising users to contact ResMed technical support to arrange for the installation of a software upgrade which will address the reported issue. Please note that this software upgrade (SX544-0401) addresses the circuit disconnection alarm issue reported previously (RC-2015-RN-00391-1) as well as the external battery power issue reported in this current recall notification. This action has been closed-out on 05/09/2016. |
| Contact Information |
02 8884 2766 - ResMed |