The FDA is getting the word out on a mandatory software update from Philips for its Trilogy line of portable life support ventilators, used in both hospitals and the home.
Philips’ Respironics division previously notified U.S. customers of the correction in mid-July, urging them to download and install version 1.05.10.00 for its Trilogy Evo, Trilogy EV300, Trilogy Evo O2 and Trilogy Evo Universal models.
The agency labeled the recall effort as Class I, its most serious, though no devices need to be returned to the manufacturer. The FDA said it has since received reports of nine related injuries and one death.
The Trilogy ventilators are designed to provide CPAP and breathing support in a variety of settings, including for people using a wheelchair or personal vehicle, or those being transported by an ambulance.
The update aims to correct a number of issues, including inaccurate displays of oxygen delivery levels—where the patient may receive less than described—as well as bugs that have caused false power loss or battery-depleted alarms, or other miscalculations.
The new software also adjusts the maximum alarm volume to meet standard requirements, according to the FDA, and adds a high-priority “Vent Service Required” alert related to contamination of the mesh covering the ventilator’s flow sensor.
A previous Class I recall was issued by the agency for the same devices in mid-2023, spanning some 120,000 pieces of hardware, after dirt and dust was found to build up in air vents and restrict the flow of oxygen. Since then, the company has updated user manuals to require the use of a Philips-approved particulate filter.