(Reuters) – The U.S. Food and Drug Administration said on Tuesday that it is alerting patients about a safety issue with Dutch healthcare technology company Philips’ machines used for treatment of obstructive sleep apnea.
The FDA said that it has received reports of people facing thermal issues such as fire, smoke, burns, and other signs of overheating while using Philips’ DreamStation 2 CPAP machines.
The agency said the reports indicate that the issues may be related to an electrical or a mechanical malfunction of the machines.
Amsterdam-based Philips has been grappling with the fallout of the global recall in June 2021 of millions of respirators used to treat sleep apnea over worries that foam used in the machines could become toxic.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shailesh Kuber)