| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00195-1 |
| Product Name/Description |
Astral 100 and Astral 150 ventilators
Affected Product: Astral ventilators manufactured between 2013 and 2019
Multiple serial numbers
ARTG 219429
(Portable ventilator electric) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
ResMed’s Astral ventilator is designed to sound a Total Power Failure alarm, for at least 2 minutes, when a Total Power Failure occurs. It has been identified that a component problem in affected ventilators may cause this alarm to sound for less than 2 minutes, or in some cases, to not sound at all (Note: this alarm is only activated when there is a Total Power Failure).
This problem does not affect the ability of the Astral ventilator to provide ventilation. All other alarms (including low and critically low battery alarms) will function as normal.
Phase 1 of this action was completed as part of recall action RC-2023-RN-00744-1; this action is aimed to address phase 2. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Phase Two: R6.2 Software Release:
In September 2023, ResMed updated the Astral service process to improve detection of this issue during service. ResMed will continue to replace circuit boards for ventilators that are identified in service to be affected by this issue.
In March 2024, ResMed released SX544-0603 Astral Software application Release 6.2 for Astral 100/150 ventilators to improve detection of this issue during ventilator use.
All ResMed service centres will upgrade the software of any Astral 100/150 ventilator to SX544-0603 Astral Software application Release 6.2, when returned for any service activity.
It is mandatory that all affected Astral ventilators are upgraded to this latest software version by the end of March 2025. |
| Contact Information |
tbc |