Omnilab Advanced Domestic and Omnilab Advanced Domestic Core

The affected products feature a ventilator inoperative alarm, which occurs when the ventilator detects an internal error or a condition that may affect therapy. This may manifest in the following ways:

• the device may reboot intermittently for 5-10 seconds (stops providing therapy, screen goes blank during the reboot, and there is a single audible alert), restarting therapy, and returning to delivering therapy with same patient settings.

• the device may reboot intermittently for 5-10 seconds (stops providing therapy, screen goes blank during the reboot, and there is a single audible alert), restarting therapy, and returning to delivering therapy but with factory default settings.

• when there are three (3) reboots within a 24-hour period, the device will enter a ventilator inoperative state (therapy stopped, audible and visual alarms present).

• the device may enter a ventilator inoperative state without a reboot preceding this condition.

Any of the above scenarios could result in interruption and/or loss of therapy which may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

Recall start date: March 25, 2024