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Astral ventilators

Official notice

13 Oct 2023

Last checked

13 Oct 2023

Medium riskHealth Canada

An official Health Canada notice concerns Astral ventilators. 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 Published 2023-10-13.

What to do now

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

Recall number

74413

Official notice

2023-10-13

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74413

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Affected products

Product 1

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

Product 2

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

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Resmed, Astral Ventilators.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74413

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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