FDA says Philips filed 21,000 reports on bad foam Aug-Oct.

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. "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.

On Wednesday, the U.S. Food and Drug Administration (FDA) 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 recalled 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 many reports are a result of the 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.