Philips Begins Repair, Replacement of Recalled Sleep Apnea Machines

The recall affected an estimated 3 million to 4 million devices globally, based on the company’s production and shipment data. The devices were distributed from July 2009 to April 2021, and over half of them were sold in the U.S. The majority of the recalled products are the first-generation DreamStation machines. DreamStation 2 devices are not affected.

Philips is aware of consumers finding black debris within the air-path tube and feeling sick. Potential risks from exposure to the foam include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects.

The specific Philips bi-level positive airway pressure (bi-level PAP), continuous positive airway pressure (CPAP) and mechanical ventilator devices that were recalled are listed by the company here with steps for consumers to take.

The company said that it sent letters to users with instructions for registering online to have affected devices repaired or replaced. Anyone who didn’t receive a letter should call Philips at 877-907-7508.

Sleep apnea in older adults

Sleep apnea is a common condition in the U.S. that occurs when the upper airway becomes blocked during sleep, reducing or stopping airflow. The majority of those affected with sleep apnea remain undiagnosed. A mechanical device such as a CPAP machine can be used to treat sleep apnea by pumping air through a tube into a mask worn by a person with sleep apnea.

The risk for sleep apnea increases as you get older. Sleep apnea may affect between 38 percent and 68 percent of people over 60, a study from the Centers for Disease Control and Prevention (CDC) found. According to the National Institutes of Health (NIH), normal age-related changes in how the brain controls breathing during sleep partially explain the increased risk with age. Another reason may be that more fatty tissue builds up in the neck and tongue as we get older.

Other causes of sleep apnea include obesity, large tonsils, endocrine disorders, neuromuscular disorders, heart or kidney failure, genetics, and premature birth.

Editor’s note: This article, originally published June 15, 2021, has been updated to reflect the FDA’s recall classification and complaints received.

Aaron Kassraie writes about issues important to military veterans and their families for AARP. He also serves as a general assignment reporter. Kassraie previously covered U.S. foreign policy as a correspondent for the Kuwait News Agency's Washington bureau and worked in news gathering for USA Today and Al Jazeera English.