The Food and Drug Administration says 561 deaths have been reported in connection to recalled Philips devices to treat obstructive sleep apnea and other breathing disorders.
The grim tally comes days after Philips said it would stop selling the machines in the U.S. in a settlement with the FDA and the Justice Department expected to cost roughly $400 million, the company disclosed in a regulatory filing.
The tentative agreement, which must be approved by a U.S. court, calls for the company to keep servicing apnea machines already being used while stopping to sell new ones until specific conditions are met.
Claims for financial losses related to the purchase, lease or rent of the recalled machines can be now be lodged in the wake of a proposed class-action settlement reached in September.
Claims for financial losses related to the purchase, lease or rent of the recalled devices can be made, with eligible users entitled to:
Roughly 30 million people have sleep apnea, a disorder in which one's airways become blocked during rest, interrupting breathing, according to 2022 data from the American Medical Association.
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