The Recall Desk
SevereFDA (Devices)·Z-1750-2015·Announced 2015-06-17

ResMed Astral Ventilator Recall Due to Alarm Disabling Hazard

ResMed is recalling Astral 100 and 150 ventilators because clinicians can disable all alarms, including circuit disconnection alerts, posing a risk of insufficient ventilation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of major severity harm to ventilator-dependent patients due to the potential for insufficient ventilation.

Plain-English summary

ResMed Ltd. is recalling 1,519 units of the Astral 100 (Model No. 27001) and Astral 150 (Model No. 27003) ventilators. The recall is classified as Class II by the U.S. Food and Drug Administration.

The hazard involves the device's ability to allow clinicians to disable all alarms, including those that detect circuit disconnection. Inappropriate disabling of these alarms in ventilator-dependent patients can lead to insufficient ventilation and insufficient expiratory pressure, which can result in major severity harm.

The affected units were distributed worldwide, including in the United States, Uruguay, and Canada. Specific serial numbers are listed in the official recall documentation. Consumers and healthcare facilities should check their device serial numbers against the recall list and contact ResMed for instructions on corrective action.

The recalled product

Product
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
Manufacturer
ResMed Ltd.
Category
Medical Device — Ventilator
Hazard
Affected units
1,519

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · ResMed Ltd.

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