AMSTERDAM — Technology company Royal Philips has issued a voluntary recall on millions of sleep apnea devices and ventilators over concerns that a noise-reducing foam used in the machines could cause harmful health impacts for users.
The recall relates to specific models of Philips Bi-Level Positive Airway Pressure, Continuous Positive Airway Pressure, and mechanical ventilator devices — most of them from the first generation "DreamStation" product line.
The models at issue use a polyester-based polyurethane sound abatement foam. Though Philips reported a low complaint rate on these devices, the company determined that the foam could degrade into particles that may enter the air pathway and be ingested or 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,” said Frans van Houten, CEO of Royal Philips. “In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, 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.”
While users of the BiLevel PAP and CPAP devices are advised to discontinue use and consult with a medical provider to find an alternative, people on the ventilator machines are asked not to immediately stop use, as the benefits of continued use "may outweigh the risks" of the potential health affects that are the subject of the recall.
There have been no reports of deaths from these issues thus far, Philips said, but exposure to particulates or chemical off-gassing from the foam can cause a range of symptoms, including possible toxic and carcinogenic effects.
For more information on the specific models and what you should do if you use one of these devices, visit the Philips recall page here.