Philips to Halt Sleep Apnea Machine Sales in U.S. Over Safety Concerns

Philips Respironics will halt sales of new sleep apnea machines in the U.S. in a settlement with the Food and Drug Administration (FDA) over safety hazards with the devices, the company announced Monday in a filing with the Securities and Exchange Commission.

Millions of Philips CPAP and BiPAP devices were recalled in June 2021 over concerns that users may ingest or inhale degraded foam, posing risks including cancer and other health complications. The FDA cited over 105,000 complaints associated with the devices, including at least 385 deaths.

Last September, Philips agreed to pay $479 million in part of a class action settlement to anyone who purchased, leased or rented one of the devices. Most recently, a warning was issued on Philips DreamStation 2 CPAP machines after the FDA received over 270 complaints of them overheating.

Sales halted

Although the company will continue to service the devices already purchased by health care providers and patients, new ones will not be sold in the U.S. until the requirements of a multiyear consent decree are met, the regulatory filing stated. Meanwhile, Philips put aside 363 million euros to comply with the agreement’s terms.

“Patient safety and quality remain Philips’ highest priority across the company,” said CEO Roy Jakobs in a statement. “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.”

Once the agreement is finalized and sent to court for approval, it will provide Philips with a list of “defined actions, milestones and deliverables to demonstrate compliance with regulatory requirements,” the company said.

The FDA said it won’t provide a comment until the agreement has been filed with the court.