Ventilator Recall Issued With Warning of ‘Serious Injuries or Death’

The U.S. Food and Drug Administration (FDA) has ordered a software recall for a type of ventilator, for fear of “serious injuries or death.”

The ventilators—the Philips Respironics, Inc. Trilogy EVO, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal—have been assigned a Class I recall, which is the most serious type of recall that the FDA has.

This is because the software on these respirators has a fault, and all products from these lines need an urgent software update before they can be safely used.

“Please be aware, this recall is a correction, not a product removal. Philips Respironics is providing a software update for its Trilogy Evo continuous ventilators,” the FDA statement reads.

This applies to all the above products distributed between March 20, 2019 and February 16, 2024, which amounts to around 90,905 respirators in the U.S.

Hospital respirators, often referred to as mechanical ventilators, are critical devices used in medical settings to assist or replace spontaneous breathing in patients who are unable to breathe adequately on their own. These machines are especially vital in intensive care units for patients who have severe respiratory conditions or during surgeries. Air can be delivered through a mask (non-invasive ventilation) or more commonly via an endotracheal or tracheostomy tube (invasive ventilation), where the tube is inserted into the patient’s airway, ensuring air is delivered directly into the lungs.

The Phillips Trilogy ventilators are controlled by a microprocessor that operates the blower for breathing support. They are used in medical, home, and non-emergency transport.

According to the FDA recall, the latest software version of the devices may cause the device to show a “battery depleted” or “loss of power” alarm despite still having power, which may then cause the ventilator to stop ventilating altogether during the alarms if it is operating only on battery power.

This could therefore lead to the patient being totally unable to breathe, and even death if not rectified.

“All Trilogy Evo ventilators (Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300) are susceptible to this problem, except those ventilators with the software version 1.05.06.00 installed,” the FDA explained.

This is due to a malfunction in the microprocessor’s algorithm that calculates the remaining battery life.

This fault may only occur in a specific set of scenarios: When the ventilator is operating in CPAP or PSV mode, and it does not detect any respiratory effort from the patient for at least 10 minutes and 45 seconds.

Thankfully, no reports of any deaths from this fault have been recorded.

Philips Respironics, Inc. has sent instructions on how to update the respirators to all customers, along with advice on how to operate them before the software is updated.

Newsweek has contacted Philips Respironics, Inc. for further comment via email.

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