Philips Respironics Trilogy Evo Ventilator Recall Identified as Class I

FDA today identified Philips Respironics Trilogy Evo continuous ventilator recall as Class I, over a month after the company initiated the voluntary correction in March.

The ventilators affected by the recall — Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal — use a microprocessor-controlled blower to provide pressure support, pressure control, or volume control during breathing support. The recall of the devices comes as a result of the company’s “post market surveillance activities, and subsequent root cause analysis,” due to Philips “intensified… efforts to strengthen patient safety and quality across the company,” according to a statement from Elco van Groningen, Philips global external relations director, sent to MD+DI when the recall was initiated. The recall is considered a correction, not a product removal.

Notifying customers on March 19 through an Urgent Medical Device Correction Notice, Philips urged users to update the ventilators to the latest software version (1.05.06.00) due to a possible power malfunction that can cause the device to issue a “battery depleted” or “loss of power” alarm “while sufficient power is still available, resulting in a sudden loss of ventilation while the device alarms,” according to the FDA filing. “All Trilogy Evo ventilators… are susceptible to this problem except those ventilators with the software version 1.05.06.00 installed.”

The loss of power alarm will stop therapy while operating on battery power alone. A battery depleted alarm, however, will continue therapy if plugged into a permanent power source like AC or DC power. The issue has been reported to happen when the ventilators have software other than version 1.05.06.00 installed, are operating in CPAP or PSV mode, and are not able to detect the respiratory effort of the patient for over 10 minutes. Currently, there have been no reports of serious injury or death related to the recall. Of note, if operating the device in modes other than CPAP or PSV, no additional mitigations are required.

“In March 2024, Philips Respironics notified customers of the Trilogy Evo ventilator product family that due to a potential malfunction of the software algorithm that calculates the remaining battery life, under specific circumstances these ventilators can issue a Battery Depleted alarm or Loss of Power alarm while sufficient power is still available,” Steve Klink, head of global external relations at Philips, said in a statement sent to MD+DI. “This issue only occurs when the device is operating on firmware other than 1.05.06.00, is in CPAP or PSV mode, and the device is not able to detect the respiratory effort of the patient for at least 10 min and 55 seconds.”

The updated software is available for download and has been since the March notification. Customers can download the latest software version for free on MyP4P.

If not updated, ventilator users should implement the following safety measures, according to the company:

Outside the United States, the recall has been identified as Class II by the Australian TGA and Health Cananda.