Overview
- 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.