FDA says Philips filed 21,000 reports on bad foam Aug-Oct
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[November 23, 2022]
AMSTERDAM (Reuters) - The U.S. Food and Drug Administration (FDA)
on Wednesday said Philips filed 21,000 medical device reports in
connection with faulty foam in its ventilation and sleep apnoea devices
in the Aug-Oct 2022 period.
Philips has been recalling 5.5 million such devices since June 2021
after it became aware that a foam part can deteriorate and threaten
In a statement, Philips said that it believes the large number of
reports are a result of publicity around the issue, which has wiped 30
billion euros off its market valuation.
"The vast majority, 93%, of the approximately 90,000 medical device
reports filed since April 2021 are alleged technical malfunctions that
do not involve serious injury," the company said.
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Signage is seen outside of the Food and
Drug Administration (FDA) headquarters in White Oak, Maryland, U.S.,
August 29, 2020. REUTERS/Andrew Kelly
(Reporting by Toby Sterling, Editing
by Louise Heavens)
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