Omnilab Advanced, Domestic and 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, restarting therapy, and returning to delivering therapy with same patient settings.

• The device may reboot intermittently for 5-10 seconds, 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.

• 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