Public recall detail

F&P Airvo 3

2024-08-29

medium
Recall Safety notice
Quick summary

Quick summary: F&P Airvo 3. Date: 2024-08-29.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: F&P Airvo 3. Date: 2024-08-29.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandFisher And Paykel Healthcare Ltd.
ProductF&P Airvo 3
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75987

Affected products

ProductF&P Airvo 3
LotContact the manufacturer.
ModelPT301CA
Serial numberContact the manufacturer.
DescriptionF&P Airvo 3

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

What you should do

  • Customer will be contacted to arrange for software update.
Additional official information
AudienceGeneral public Healthcare
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesFisher And Paykel Healthcare Ltd. 15 Maurice Paykel Place East Tamaki, Auckland, New Zealand, 2013
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75987
Background{}
CompaniesFisher And Paykel Healthcare Ltd. 15 Maurice Paykel Place East Tamaki, Auckland, New Zealand, 2013
AudiencesGeneral public Healthcare
Source updated2024-08-29

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...