| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00730-1 |
| Product Name/Description |
Airvo 3 NIV Respiratory Support Device
Product Code: PT311AN
Software Versions: 1.2.0 – 1.5.1
Manufacturing Date Range: 2021-03-17 – 2024-03-14
ARTG 381238
(Fisher & Paykel Healthcare Pty Ltd - Professional BPAP/high-flow respiratory unit) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
When flow alignment alarm 3.2.2 occurs in Airvo 3 NIV devices set up with High Pressure Oxygen (HPO) and running software version 1.5.1 or earlier, the device will deliver room air only. If this happens, a patient may experience oxygen desaturation that could lead to hypoxia. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Once the acknowledgement form is received, Fisher and Paykel Healthcare will contact customers to arrange for the affected product to be updated to software version 1.5.2.
Until the software is updated customers can continue to use the device. When using the device customers must follow all instructions including warnings and cautions in the user manual, particularly those in Sections 1 and 2. If alarm 3.2.2 occurs, customers are to follow the instructions on the screen.
This action has been finalised on 26/9/2024. |
| Contact Information |
(03) 9871 4900 - Fisher & Paykel |