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Rappel de produits de santé

Astral Ventilators and External Battery (2016-08-17)

Starting date:
August 17, 2016
Posting date:
August 26, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-60000

Affected Products

A. Astral 150
B. Astral External Battery

Reason

When astral ventilators are used with the internal battery as the sole power source, it is important to note that failure of the internal battery can lead to cessation of therapy without the low battery or critically low battery alarm sounding, even when the battery indicates that it is charged.  This could put patients at risk to not getting therapy.

Affected products

A. Astral 150

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

27003

Companies
Manufacturer
Resmed Limited
1 Elizabeth Macarthur Drive
Bella Vista
2153
AUSTRALIA

B. Astral External Battery

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

27919

Companies
Manufacturer
Resmed Limited
1 Elizabeth Macarthur Drive
Bella Vista
2153
AUSTRALIA