Philips Respironics CPAP machines and masks
Philips Respironics made the DreamStation, DreamStation Go, DreamStation 2 and older System One (REMstar and BiPAP) sleep therapy machines. On June 14, 2021 it recalled certain CPAP, BiPAP and ventilator devices (about 15 million worldwide, per the FDA) made before April 26, 2021 because the polyester-based polyurethane (PE-PUR) sound abatement foam inside could break down into particles and give off chemicals, and in July 2021 the FDA classified it as a Class I recall, the most serious type. Philips says it voluntarily stopped selling CPAP and BiPAP sleep therapy devices in the US in 2021, and under a consent decree entered by a federal court on April 9, 2024 (terms first announced January 29, 2024) it will not resume selling new CPAP or BiPAP devices in the US until the decree's requirements are met. It can still service devices already with patients and sell masks, accessories, consumables and replacement parts in the US.