FreeO2 Automated Oxygen Therapy Device Adult & Pediatric – Version HW 2.3

Health product recall

FreeO2 Automated Oxygen Therapy Device Adult & Pediatric – Version HW 2.3

 

Brand(s)

Oxynov, Inc.

Last updated

2026-10-08

Summary

Product

FreeO2 Automated Oxygen Therapy Device Adult & Pediatric – Version HW 2.3

Issue

Medical devices – Performance

What to do

Contact the manufacturer if you require additional information.

Audience

Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
FreeO2 Automated Oxygen Therapy Device Adult & Pediatric Version HW 2.3 FO2-110-00

Issue

Under specific conditions following a deep battery discharge, error 29515 may occur during startup of a FreeO2 HW 2.3 device using software package 1.4.2 and prevent its use. The update to software package 1.4.3 corrects this issue and restores the expected startup behaviour.

Additional information

Details

Original published date: 2026-10-08

Alert / recall type

Health product recall

Category

Health products – Medical devices – Anaesthesiology

Companies

Oxynov, Inc.
725, Boulevard Lebourgneuf, Quebec, Quebec, Canada, G2J 0C4

Published by

Health Canada

Audience

Healthcare

Recall class

Type II

Recall date

2026-09-30

Identification number
RA-82749

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Date modified:
2026-10-08