FDA Policy/General

Phillips Ventilator Correction is Class 1 Recall

FDA has classified a correction involving certain ventilators manufactured by Philips as a Class I recall, warning that continued use of the devices without recommended updates could lead to serious injury or death. The action affects multiple models in the Philips Respironics Trilogy Evo platform, including Trilogy Evo, Trilogy EV300, Trilogy Evo O2 and Trilogy Evo Universal ventilators. Rather than removing the devices from the market, the recall requires corrective actions, including software updates and changes to how the devices are used in clinical settings.

According to FDA, Philips notified customers in a 3/2 letter advising that all affected ventilators be updated to software version 1.05.15.00 and that clinicians immediately stop using non-pneumatic nebulizers — such as vibrating mesh nebulizers — with the devices. The company also instructed users to review updated labeling, including a User Manual Addendum, and to communicate the changes across care teams, including clinicians, respiratory therapists, and caregivers.

The recall stems from three identified issues that could compromise ventilation therapy, according to the agency.

First, the use of non-pneumatic nebulizers can alter airflow characteristics by introducing liquid aerosols, leading to inaccurate leak estimation by the ventilator. This can result in under-delivery of tidal volume without any corresponding alert on the device interface, potentially causing hypoventilation, low oxygen saturation and inadequate treatment.

Second, aerosol accumulation on internal flow sensors may degrade measurement accuracy over time. Depending on the extent of buildup, this can lead to either under- or over-delivery of tidal volume, reduced oxygen delivery, or in some cases render the ventilator inoperative. These malfunctions carry risks including lung overinflation, respiratory distress, delayed therapy and hypoxemia.

Third, the FDA said the devices may fail to trigger obstruction alarms within required timeframes—typically within two breaths or five seconds. In certain modes, alarms may be delayed by as many as four breaths, potentially postponing clinician response to airway blockages.

Philips reported three serious injuries linked to the issues as of March 6, with no deaths to date, according to the FDA notice.

The Trilogy Evo platform ventilators are used to provide continuous and intermittent positive airway pressure support for pediatric and adult patients requiring mechanical ventilation across hospital settings, transport environments and, in some cases, home care.

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