Philips OmniLab Advanced+ Ventilator Recall Issued Over Loss of Therapy Risks

A Philips Respironics OmniLab Advanced+ Ventilator recall has been announced, following at last 15 reports of injuries and one death that may have resulted from device interruptions and loss of therapy.

The Philips OmniLab Advanced+ (OLA+) recall was announced by the U.S. Food and Drug Administration (FDA) on June 28. Originally announced as an update to the devices’ instructions, the agency has declared that the action represents a Class I medical device recall, which is the most serious classification, indicating that users face a risk of severe injury or death if the ventilators fail to deliver life-sustaining oxygen.

While the recalled ventilators are not being removed from the market, the FDA warns that the OLA+ has a Ventilator Inoperative Alarm that could fail. If that happens, patients could suffer from hypoventilation, hypoxemia, hypercarbia, respiratory failure or death.

The ventilator recall comes as the manufacturer is still reeling from problems that led to a recall of several million Philips CPAP, BiPAP and ventilator machines distributed between 2009 and April 2021, which included a defective PE-PUR sound abatement foam that is prone to break down over time, releasing toxic black particles into the air pathways, tubing, mask and users lungs.

It also comes after a nearly identical Philips BiPAP recall was announced the day before, following 952 reported injuries, and 65 reports of patient deaths for the same problem with device interruptions and loss of therapy.

On April 1, 2024, Philips issued an Urgent Medical Device Recall notice to all affected customers, which called for a change in the instructions on how to use the OmniLab Advanced+ (OLA+).

The company warned at the time that when the ventilators malfunction, they may reboot intermittently for five to 10 seconds, then restart with the same patient settings. They may also restart back to the original factory settings, or enter into a Ventilator Inoperative state, stopping therapy after three reboots within 24 hours, or after no reboots at all.

Philips Respironics, Inc. indicated that patients should be immediately removed from the affected devices if the Ventilator Inoperative Alarm occurs, and switched to an alternative source of ventilation, if one is available.

The letter also suggested operators can attempt to perform a “hard reboot” of the device to force it to restart, which could temporarily restore device function.

A full list of all of the affected OLA+ ventilators, including unique device identifier numbers, is available in the recall notice.

Customers with questions should contact Philip Respironics, Inc, as 1-800-345-6443, or via email at respironics.clinical@philips.com.

Philip CPAP Recall Lawsuits

Philips Respironics has been plagued by recalls in recent years, and has faced sharp criticism from regulators over it’s handling of a massive 2021 recall, which also affected DreamStation CPAP devices and other breathing assistance machines.

As a result of problems linked to that earlier recall, 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 earlier this year that barred Philips 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 2023, 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.

To resolve personal injury and wrongful death lawsuits, the company also announced a $1.1 billion Philips CPAP recall settlement agreement in April 2023, effectively ending litigation over problems linked to the defective sound abatement foam at issue in the 2021 recall.