ResMed Ltd. recalls Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.

Recall date

May 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1750-2015

FDA classification

Class II

Brand / firm

ResMed Ltd.

Sold / distributed

Worldwide distribution. US nationwide, Uruguay and Canada.

Why it was recalled

The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of insufficient ventilation and insufficient expiratory pressure which can result in major severity harm.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.