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Health Canada Medical devices

F&P Airvo 3

Issued August 29, 2024
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
Hazard description
Performance
Product
Product name
F&P Airvo 3
Reference
ID
RA-75987