Health product recall

Fabian Ventilators

Last updated

Summary

Product
Fabian Ventilators
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue

Fabian Therapy Evolution

Software version 5.2.2

121001

Fabian Hfo Premature Infant And Paediatric Ventilator - Ventilator

Software version 5.2.2

111001
112001
113001
111001.01

Fabian +Ncpap Evolution

Software version 5.2.2

122001

Issue

The manufacturer is providing an addendum to users with additional information that supplements and clarifies the existing IFUs for the following three topics to ensure safe and proper operation of the ventilators.

1. Fabiantm flow sensor calibration requirements

2. supported exhalation membrane holders

3. setting up prico (predictive intelligent control of oxygenation)

Recall start date: March 11, 2024

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
Healthcare
Recall class
Type II
Identification number
RA-75801

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