Recall Z-1750-2015— ResMed Ltd.
Class II · Terminated
Class II FDA medical device recall by ResMed Ltd., initiated 2015-05-05, terminated 2016-04-07. It names one FDA 510(k) clearance: K133868. Product: Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.. Reason: 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..
- Recalling firm
- ResMed Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-05
- Terminated
- 2016-04-07
- Firm location
- Bella Vista, NSW, N/A, Australia
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.