The U.S. Food and Drug Administration (FDA) has issued an update to a recall affecting millions of Philips sleep apnea machines, saying that they may been linked to at least 561 reported deaths.
In a statement issued Wednesday, the agency said it has received more than 116,000 reports about the respiratory devices since April 2021, which have been found to break down and cause serious health hazards including choking, inhalation of foreign particles and increased risk of cancer.
The devices, used for sleep apnea and similar sleep disorders, were made with polyester-based polyurethane (PE-PUR) foam, which has been found to break down over time and enter the airways of people using them.
According to the FDA notice, the foam, which is used to reduce sound and vibration, degrades with use, causing “black pieces of foam, or certain chemicals that are not visible” to be “breathed in or swallowed by the person using the device.”
Philips attempted to fix this issue after an initial recall of over 5 million devices in 2021.
Philips has since agreed with regulators to stop selling these and similar devices in the U.S., and a proposed class action settlement is underway. A spokesperson for Philips shared the following statement with USA TODAY.
“Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in these medical device reports.
Importantly, the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event.
Philips Respironics investigates all received complaints and allegations of malfunction, serious injury or death.”Â
Here is what we know about the Philips sleep machine recalls.
© Copyright RawNews1st
