Official recall record

Omnilab Advanced Domestic and Omnilab Advanced Domestic Core

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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