| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00263-1 |
| Product Name/Description |
Airvo 2 devices
Airvo 2
Part numbers: PT101AZ, PT101AN
Serial number range: 120521YYYYYY - 170813YYYYYY
myAirvo 2
Part numbers: PT100AZ, PT100AN
Serial number range: 120521YYYYYY - 170813YYYYYY
ARTG 177298
(Fisher & Paykel Healthcare Pty Ltd - High-flow heated humidifier) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
The speaker in the AIRVO 2 / myAIRVO 2 Humidifier is intended to provide the user with auditory alerts and alarms under certain conditions. In devices manufactured before 14 August 2017, the speaker configuration may result in distorted, intermittent, or inaudible alarm sound levels. If an alarm condition occurs during use, and the speaker is inaudible, the visual alarm on the display will continue to alert the user of the alarm condition. A fault with the speaker will not affect the delivered therapy by the AIRVO 2/myAIRVO 2 device and the device will otherwise perform as intended. In the absence of an audible alarm, if there is an interruption of therapy, a patient may experience oxygen desaturation. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to identify and quarantine affected devices to prevent unintended use. Fisher and Paykel will arrange for affected products to be returned, where they will be destroyed, and replacement device(s) issued. Where it is not practicable to return product, appropriate destruction can be executed by the customer. A signed confirmation of destruction by the customer is required to receive a replacement device(s). |
| Contact Information |
03 9871 4900 - Fisher & Paykel Australia Customer Care |