Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
Check against the official notice below — it lists the full affected range.
ResMed Ltd. is recalling 1,519 units of the Astral 100 (Model No. 27001) and Astral 150 (Model No. 27003) ventilators that have been distributed worldwide, including throughout the US, Uruguay, and Canada. The devices contain a design flaw that allows clinicians to disable all alarms, including those that detect circuit disconnection. When these critical alarms are inappropriately disabled in patients who depend on mechanical ventilation, the result can be insufficient ventilation and insufficient expiratory pressure, potentially causing serious harm.
The recall affects ventilators with specific serial numbers listed in the recall documentation. The source does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide distribution. US nationwide, Uruguay and Canada. Quantity: 1519 units Lot/code info: Serial No. 22141256746 22141256747 22141256749 22141256750 22141256752 22141256753 22141256754 22141256755 22141256756 22141256757 22141256758 22141256759 22141256760 22141256761 22141256762 22141256763 22141256764 22141256765 22141256766 22141256767 22141256768 22141256770 22141256771 22141256773 22141256774 22141256776 22141256777 22141256778 22141256780 22141256781 22141256782 22141256783 22141256784 22141256785 22141256786 22141256787 22141256788 22141256789 22141256790 22141256792 22141256793 22141256795 22141256796 22141256797 22141256798 22141256800 22141256802 22141256803 22141256804 22141256805 22141256808 22141256809 22141256810 22141256811 22141256812 22141256813 22141269796 22141269797 22141269798 22141269800 22141269801 22141269802 22141269803 22141269804 22141269805 22141269806 22141269807 22141269808 22141269809 22141269810 22141269811 22141269812 22141269813 22141269814 22141269815 22141269817 22141269818 22141269819 22141269820 22141269821 22141269822 22141269823 22141269824 22141269825 22141269826 22141269827 22141269828 22141269829 22141269830 22141269831 22141269832 22141269833 22141269834 22141269835 22141269836 22141269837 22141269838 22141269841 22141269842 22141269843 22141269844 22141269846 22141269847 22141269848 22141269849 22141269850 22141269851 22141269852 22141269853 22141269856 22141269858 22141269859 22141269860 22141269861 22141269862 22141269865 22141269866 22141269867 22141269868 22141269869 22141269870 22141269872 22141269873 22141269874 2
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.