(Reuters) – The U.S. Food and Drug Administration said on Wednesday there have been 561 deaths reported since 2021 related to the use of Philips’ recalled ventilators and machines for treating obstructive sleep apnea.
The health regulator added that in 2023, between July and September, it received more than 7,000 medical device reports, including 111 reports of deaths related to the use of these machines.
Philips did not immediately respond to Reuters’ request for a comment.
The FDA said the medical device reports had limitations and the incidence or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports and lack of verification that the device caused the events.
Earlier this week, Philips said it would not sell new devices to treat sleep apnea in the U.S. in the coming years as it works to comply with a settlement with the FDA.
The agreement followed the recall of millions of breathing devices and ventilators used to treat sleep apnea in 2021 because of concerns that foam used to reduce noise from the devices could degrade and become toxic, carrying potential cancer risks.
(Reporting by Christy Santhosh; Editing by Krishna Chandra Eluri and Shilpi Majumdar)
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