Fabian Ventilators
Brand(s)
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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