Philips blocks sale of sleep, respiratory devices in the US for FDA consent decree

Philips has agreed to cease selling new sleep therapy and respiratory care products in the U.S., following a significant recall launched about two-and-a-half years ago. This decision is part of a consent decree with the U.S. Department of Justice, representing the FDA, as Philips addresses quality issues that led to the recall of over 15 million devices. The decree is being finalized for submission to a U.S. court.

During its fourth-quarter earnings call, Philips disclosed details of the agreement. While it will continue servicing existing devices and supplying accessories, Philips will refrain from selling new CPAP/BiPAP sleep therapy or other respiratory care devices in the U.S. until decree requirements are met.

Provisions of 363 million euros ($392 million) related to the decree were recorded in the fourth quarter, impacting full-year sales growth, which decreased from 7% to 6%. Operations outside the U.S. are unaffected, with Philips already re-entering certain international markets and initiating sales of new devices there.