April 9 (Reuters) -
A U.S. federal court issued a decree to restrict the
production and sale of Philips' new sleep apnea
machines at several facilities in the country, the Food and Drug
Administration said on Tuesday.
The U.S. District Court for the Western District of
Pennsylvania has entered into what is known as a consent decree
to curb the sale and production until certain requirements are
met.
In
January
, the Dutch health technology company had said that it will
not sell new devices to treat sleep apnea in the United States
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.
Tuesday's decree also requires implementation of a
recall remediation plan, agreed to by the FDA and Philips, to
help ensure relief is provided to patients impacted by the
recall.