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

"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.

"In March 2024, Philips Respironics initiated this recall notification as the result of our post-market-surveillance activities, and subsequent root-cause analysis. There was no report of patient injury or patient harm," Mario Fante, a spokesperson for Philips, told Newsweek.

"Philips Respironics is addressing this issue through a software update that is already available to customers in the U.S. Customers should update all impacted devices to this most recent version of software."

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

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Update 05/15/24, 1:41 p.m. ET: This article was updated with comment from Philips.