Philips recalls millions of ventilators, sleep apnea machines

On Monday, Dutch medical equipment company Philips issued a recall that affects between 3 million and 4 million ventilators an sleep apnea machines. There are concerns that a foam component of the involved machines may degrade and become toxic, the company said.

The devices involved are Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices. All these use a polyester-based polyurethane foam component to dampen the machine's sound. According to Philips, there is a risk that this foam may degrade into particles that could enter the device's air pathway and then be inhaled by the user.

“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” Philips CEO Frans van Houten said. “We are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices. Patient safety is at the heart of everything we do at Philips.”

The affected BiLevel PAP and CPAP devices can be found here, and the affected mechanical ventilators are listed here. People using the PAP and CPAP machines, mostly used to help with sleep apnea, are advised to halt usage and talk to their doctors about other treatment options. Patients using life-sustaining ventilators are urged to talk to their doctor and consider whether the potential danger posed by the foam outweighs the risks of halting use of the machine.

Philips is working with the regulatory agencies to replace the current sound abatement foam with a new material. The process is expected to take about a year, Van Houten said to Reuters. He added that Philips' entire capacity will be focused on replacing and repairing these units.