Health product recall

F&P Airvo 3

Last updated

Summary

Product
F&P Airvo 3
Issue
Medical devices - Performance
What to do

Customer will be contacted to arrange for software update. 

Affected products

Affected products

Lot or serial number

Model or catalog number

F&P Airvo 3

Contact the manufacturer.

PT301CA

Issue

This recall 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.

Software version 1.5.2 updates the software algorithm and ensures the target therapy continues in the event that this alarm occurs.

Recall Start Date: August 8, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Fisher And Paykel Healthcare Ltd.

15 Maurice Paykel Place East Tamaki, Auckland, New Zealand, 2013

Published by
Health Canada
Audience
General public
Healthcare
Recall class
Type II
Identification number
RA-75987

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