Philips to Halt Sales of Sleep Apnea Machines

The company came to an agreement with the FDA to cease sales until the machines’ health hazards can be fully addressed.

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Philips Respironics announced on Monday that it would suspend sales of all its breathing machines in the United States after coming to an agreement with the U.S. Food and Drug Administration (FDA) over ongoing issues with its sleep apnea devices.

“Patient safety and quality remain Philips’ highest priority across the company,” said Roy Jakobs, CEO of Royal Philips, in a press release. “Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologize for the distress and concern caused. We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”

Starting in 2021, the company issued a voluntary recall of some of its ventilators and CPAP machines, which millions of Americans have used to ease their breathing at night, after the FDA received reports that the foam used in the machines could disintegrate and be inhaled by users, along with resulting chemicals. According to the FDA, the machines used a polyester-based polyurethane foam to reduce sound and vibration. However, if subjected to hot and humid conditions, that foam could break down, posing a health hazard to users.

Some of the machines also caught fire as a result of overheating. Between Aug. 1 and Nov. 15, 2023, the FDA received over 270 reports of problems associated with the Philips DreamStation2 CPAP machine related to overheating.

“As a leading health technology company, our first priority at Philips is patient safety and quality,” wrote Steve Klink of the Philips Global Press Office in a press release. “We understand how important Philips Respironics’ sleep therapy devices and ventilators are to patients that use them and how they improve their lives every day and night.”

Under the guidelines of the settlement with the FDA, Philips said it must meet a list of standards in a long-term plan before it can return to selling breathing machines in the United States. In a press release, Philips said more details would be released in court. However, it did note it would continue to repair any existing devices and provide service so people may continue to use them. According to the company, Philips has remediated 99 percent of the actionable sleep device registrations.

The recall for Philips devices, including BiPAP and CPAP machines and ventilators, temporarily halted sales of new sleep therapy machines in the United States. More than 20 devices have been recalled due to a range of potential health problems reported as a result of using the products. Potential health problems include headache, skin, nose, or eye irritation, sinus infections, cough, asthma, nausea or vomiting, allergies, dizziness, or a feeling of pressure in the chest.

What Do I Do if I Have a Recalled Machine?

If you have a Philips CPAP, BiPAP, or other device that has been recalled, connect with your doctor to discuss your symptoms. The FDA also encourages individuals to report the problem through the MedWatch Voluntary Reporting Form.

The FDA also urges consumers to register their devices on the Philips website. Consumers must locate the serial number on their device to register it on the website.

If you do not find your device on the list of recalled models, consider contacting the medical equipment supplier that supplied your device. It will likely be able to tell you if your machine has been recalled.

The FDA warns consumers against stopping the use of their devices before consulting their physicians.

“For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use,” the FDA wrote in a press statement. “If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device.”