FDA and Philips Advise Continued Use of Replacement CPAP Devices Amid Safety Concerns

Despite links to 561 deaths from recalled devices, Philips to cease new sales in the U.S. but continue servicing existing machines.

The FDA and Philips recommend continuing the use of replacement CPAP devices amid safety concerns, highlighting the use of silicone foam in remediated devices.
561 deaths have been linked to the breakdown of PE-PUR foam in Philips' recalled sleep apnea machines, with more than 116,000 reports of malfunctions.
Philips has agreed to stop selling new sleep therapy and respiratory care devices in the U.S. but will continue servicing existing devices.
A class-action settlement is underway, with Philips agreeing to pay at least $445 million in compensation to users of the recalled devices.
The FDA has issued recalls and safety warnings for certain Philips CPAP machines, including a recent alert for DreamStation 2 machines due to overheating risks.