Philips Trilogy EVO Ventilator Recall Issued Due to Software-Related Power Malfunction Risk

Philips Respironics continues to face issues with U.S. regulators over problems with its breathing assistance devices, after the FDA recently announced a recall impacting more than 100,000 Trilogy EVO ventilators, which may contain software defects that the federal regulators determine pose a serious risk of injury or death for patients.

Although Philips first issued a “product correction” notice about the software problems in March, the FDA recently determined that the action constitutes a Trilogy EVO ventilator recall, indicating that continued use of the devices could result in a loss of breathing support for patients.

Trilogy EVO ventilators are used by individuals who require assistance with breathing, providing continuous or intermittent breathing support in hospitals, homes, and non-emergency transport settings. The FDA has determined that the product correction constituted a Class I medical device recall, which is the most serious classification.

This comes after years of problems Philips has faced with it’s breathing machines, including millions of CPAP, BiPAP and mechanical ventilators recalled in 2021, due to a toxic sound abatement foam that has been linked to reports of cancer, lung damage and other respiratory injuries. As a result of that recall, the manufacturer recently announced a $1.1 billion Philips CPAP settlement to resolve personal injury lawsuits and medical monitoring class action claims.

In this latest recall notice, customers were urged to update to the latest software version for the Trilogy EVO ventilators, due to an issue that can result in a “Battery Depleted” or “Loss of Power” warning, even when power is still available. This can cause a sudden loss of ventilation when the devices’ alarms go off.

The recall notice indicates this situation occurs when the software has a version other than 1.05.06.00, the latest version, installed, the ventilator is being operated in CPAP or PSV mode, and the ventilator is not able to detect the respiratory effort of the patient for at least 10 minutes, 45 seconds. All of these factors must be present for the problem to occur, according to Philips.

To date, no injuries or incidents linked to the problem have been reported to the FDA.

Trilogy EVO Ventilator Recall

The recall affects all Trilogy EVO models, including the Trilogy EVO, Trilogy EV300, Trilogy EVO O2, and Trilogy EVO Universal, and all software versions except the latest, 1.05.06.00. The affected devices were distributed between March 20, 2019, and February 16, 2024.

An estimated 90,905 devices sold in the U.S. are affected. Philips recommends all customers who have or use the affected devices ensure that the latest software update has been installed to avoid the potential problem.

For devices that have not yet been updated, Philips recommends users ensure the Backup Ventilation is set to ON, and the apnea interval is set appropriately based on the patient’s clinical needs. The manufacturer also recommends keeping the device plugged into AC or DC power as much as possible, keeping an alternative form of ventilation nearby, not leaving patients unsupervised while the devices are operating on battery power alone, and continuing to follow standard monitoring protocols for ventilated patients.

U.S. customers with questions can contact Philips Respironics at 1-800-345-6443 for homecare customers and 1-800-722-9377 for hospital customers.

Philips CPAP and Breathing Device Recalls

This is the latest in a series of regulator actions taken against Philips involving problems with it’s breathing assistance machines, most of which stem from the bungled handling of a Philips CPAP recall that affected millions of devices in 2021.

The manufacturer has faced sharp criticism for selling millions of devices that contained a toxic sound abatement foam, which was found to degrade and release small black particles and chemicals directly into the machine’s air pathways.

Over the past two years, thousands of Philip CPAP lawsuits have been filed by former users left with severe lung damage, respiratory injuries and other injuries, and the FDA has identified serious deficiencies in the company’s recall and repair program, which has further increased the risks faced by owners of the machines.

The FDA repeatedly warned that the company was failing to properly repair and replace the recalled units, announcing a consent decree last month that barred the manufacturer from manufacturing and distributing CPAP and other breathing assistance devices in the U.S. until the company shows it can meet requirements set by federal regulators.

In September, Philips announced it will pay at least $445 million in a CPAP recall class action settlement to individuals who bought, rented or leased one of the impacted devices, and another $34 million to health insurance companies and others who paid to reimburse users to replace the machines.

Then, last month, the company announced it had reached a $1.1 billion Philips CPAP recall settlement agreement to resolve the personal injury lawsuits and medical monitoring claims.

The personal injury and medical monitoring settlement agreement still needs to also receive final approval from a federal judge.