| TGA Action ID |
RC-2025-RN-00782-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Fisher & Paykel Healthcare Airvo 2 and myAirvo 2 Humidifier
Product Code: PT100AN, PT101AN
Device Identifier: 09420012447319, 09420012447333 |
| ARTG Number |
177298 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
The Airvo 2 and myAirvo 2 device has an audible alert that sounds for at least 120 seconds when the unit is unintentionally disconnected from a power source. The Disinfection Kit User Manual has been updated to include a regular test of this alert, to be carried out in between patient uses.
Fisher & Paykel (F&P) have updated the manual due to reports of the audible alert sounding for less than 120 seconds, which may delay user awareness to reconnect power. |
| Instructions for Customers/Users |
F&P have updated the Disinfection Kit User Manual with a step to check the audible alert.
Users may continue to use Airvo 2 and myAirvo 2 devices with appropriate patient monitoring as per the User Manual. When using the device, all instructions, including warnings and cautions in the User Manual must be followed.
This action has been finalised on 16/12/2025. |
| Action Commencement Date |
15/09/2025 |
| Responsible Entity |
|
| Contact Information |
03 9871 4900 - Fisher & Paykel Healthcare Australia Customer Care |