FREEO2 AUTOMATED OXYGEN THERAPY DEVICE (2020-12-10)

Starting date:

December 10, 2020

Posting date:

December 24, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74643

Last updated:
2020-12-24

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  Reason
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  Affected products

Affected Products 

FREEO2 AUTOMATED OXYGEN THERAPY DEVICE

Reason

When the flow rate calculated by the device reaches the maximum threshold, i.E. 20L / min for adult patients or 10l / min for paediatric patients, the device generates a critical alarm and triggers a safety protocol with the result of temporarily reducing the oxygen supply at 8l / min for adult patients and at 7l / min for paediatric patients. This reduction is only temporary (a few seconds). However, if the calculated flow rate reaches the limit again, the alarm will be triggered again, and several cycles of flow fluctuations may occur.

Affected products