Philips Respironics initiated a Class I recall for Trilogy EV300 continuous home-use ventilators (Software Version 1.05.15.00) after discovering that using non-pneumatic nebulizers with these devices may result in a discrepancy between the set tidal volume and the tidal volume actually delivered to the patient. Class I is the most serious recall classification, indicating reasonable probability of serious adverse health consequences or death. The recall affects devices distributed worldwide, including throughout the US.

Healthcare providers and durable medical equipment suppliers should immediately identify any Trilogy EV300 devices in use or inventory, notify patients and caregivers of the tidal volume discrepancy risk when non-pneumatic nebulizers are co-used, and contact Philips Respironics for replacement options or repair instructions. Patients should not stop using their ventilator without consulting their healthcare provider. The recall is ongoing, and Philips is expected to provide further instructions through their customer notification process.