| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00732-1 |
| Product Name/Description |
Airvo 3 Respiratory Support Device
Product Code: PT301AN
Manufacture Date Range: 17/03/2021 – 14/03/2024
Software Versions: 1.2.0 – 1.5.1
ARTG 381134
(Fisher & Paykel Healthcare Pty Ltd - High-flow heated humidifier) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
This problem relates to specific versions of software of the Airvo 3, and how the device responds when flow alignment alarm 3.2.2 occurs.
When this happens in Airvo 3 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 |
Customers should:
1. Immediately identify affected product by checking the product label underneath the base of the device.
2. If the device is still within inventory, put the product in quarantine to prevent ongoing distribution until a F&P Representative has contacted with next steps.
3. Once the response form is received a F&P Representative will contact customers regarding the update of software to version 1.5.2.
Updated 9.09.24: Devices will be replaced if the software cannot be updated as planned. (e.g. an upload error or unrelated device error identified).
Until the software is updated, customers may continue to use the Airvo 3 device. When using the device, all instructions, including warnings and cautions in the Airvo 3 User Manual must be followed, particularly those in Sections 1 and 2.
If alarm 3.2.2 occurs, customers should follow the onscreen instructions. |
| Contact Information |
03 9871 4900 - Fisher & Paykel Australia Customer Care |