Health product recall

Astral Ventilators

Brand(s)
Last updated

Summary

Product
Astral Ventilators
Issue
Medical devices - Performance issue
What to do

Manufacturer provided instructions on how to response. Will implement corrections when available.

Audience
Healthcare
Industry

Affected products

Affected products Lot or serial number Model or catalog number
Astral Ventilators Contact the manufacturer. 27003
Astral Ventilators Contact the manufacturer. 27001

Issue

Resmed's Astral ventilator is designed to deliver a Total Power Failure (TPF) audible alarm for at least 2 minutes to alert the carer/clinician when the ventilator experiences a total loss of power that results in a stop of ventilation. The TPF audible alarm is powered by an electrical component known as a supercapacitor. This component degrades over time, which may cause the TPF alarm to sound for less than 2 minutes, or in some cases, to not sound at all.

Recall start date: September 13, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

ResMed Pty Ltd

1 Elizabeth Macarthur Drive, Bella Vista, New South Wales, Australia, 2153

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-74413