FDA says Philips filed 21,000 reports on bad foam Aug-Oct.
AMSTERDAM, Nov 23 (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 users’ health.
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.
