Health product recall

Fabian HFOi Ventilator

Last updated

Summary

Product
Fabian HFOi Ventilator
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or Serial Number Model or catalog number
Fabian HFOi Ventilator More than 10 numbers, contact manufacturer. 113001, 7200.I

Issue

Bias flow selection for NO system usage is missing from the user interface of Fabian HFOi Ventilators following incorrect selection of device configuration during a software update. This is caused by human error and there is no defect in the device or its software.

Recall start date: Mar 28, 2022

Additional information

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

Acutronic Medical Systems Ag

Fabrik Im Schiffli, Hirzel

Switzerland, 8816

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type I
Identification number
RA-64066

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