Philips halts sleep devices’ U.S. sale
The US body said it had received reports ‘such as fire, smoke, burns and other signs of overheating’ from people using the machine
Daily TribuneThe US body said it had received reports ‘such as fire, smoke, burns and other signs of overheating’ from people using the machine
USER
The Hague, Netherlands — Under-fire Dutch medical device maker Philips said Monday it would halt new sales of sleep machines in the United States after a series of recalls that continued to weigh on results.
The firm trimmed its losses for 2023 compared with the previous year, as it seeks to bounce back from what it had described as a “very difficult” 2022.
Philips posted losses of 463 million euros over the full year, compared with 1.6 billion euros in 2022, with chief executive Roy Jakobs hailing “strong results.”
“While there is more work to be done, the progress we achieved in a volatile world lays a solid foundation for sustained performance,” Jakobs said.
Since 2021, the company has been battling a series of crises over its DreamStation machines for sleep apnoea, a disorder in which breathing stops and starts during sleep.
“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,” said Jakobs.
The firm said it had clinched a “consent decree” deal with US authorities that consists of a “roadmap” of targets to allow Philips to conform with regulatory requirements.
“Until the relevant requirements of the consent decree are met, Philips Respironics will not sell new... sleep therapy devices or other respiratory care devices in the US,” the company said.
It said it had set aside a provision of 363 million euros in the fourth quarter to settle the deal, which still needs to be finalized and requires court approval.
“We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward,” Jakobs said.
The firm’s latest woes came in November when the US Food and Drug Administration warned that its new “DreamStation 2” machine to help patients sleep risked overheating.
