Fabian HFO and Fabian +nCPAP Evolution Ventilators (2020-10-05)

Starting date:

October 5, 2020

Posting date:

October 20, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74147

Last updated:
2020-10-20

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  Reason
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  Affected products

Affected Products

Fabian HFO and Fabian +nCPAP Evolution Ventilators

Reason

Ventilator can experience a malfunction associated with over-delivery of peak-inspiratory pressure with delayed or absent alarm during use of the volume guarantee (VG) function.

Affected products