Product Wiki · Recalls · Health Canada — Medical Devices

Fabian HFOi Ventilator — recall 64066

Health Canada — Medical Devices · Canada · 2022-04-12 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
64066
Date of alert
2022-04-12
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Anaesthesiology
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/fabian-hfoi-ventilator

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