Philips has issued a voluntary recall of software for its Trilogy Evo ventilator series and a warning to patients not to use non-pneumatic nebulizers with the devices, as they may not deliver the needed therapy.
The recall was issued March 2 and posted on the FDA’s website April 2, and has been classified as a Class I recall—the regulatory agency’s most serious classification.
The action covers all Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 devices.
“Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient,” the company said in the posting. “This can lead to under-delivery of therapy to the patient.”
The recall affects more than 113,700 devices distributed globally. Back in 2024, Philips sent a product notice related to an obstruction alarm compliance failure and that a software update to correct the problem was pending.
The company recalled more than 5.5 million ventilators, CPAP and BiPAP machines in 2021. In late 2023, the FDA issued a safety communication warning users of DreamStation 2 devices that overheating may occur, potentially leading to fire, smoke, burns and more.