Philips will pay 288 million euros to settle an investigation related to its recall of millions of sleep and respiratory devices.

Philips plans to pay the settlement in the first quarter of 2027. It is subject to finalization of relevant documentation, the company said.

Philips first noted problems with the soundproofing foam used in its devices in 2018, adding foam replacement to the maintenance schedule for its machines after finding it could degrade into particles. The company had received complaints dating back as far as 2014. However, Philips did not disclose the change to the FDA, which discovered the foam issues during a 2021 inspection.

Through a consent decree, a rare action for the FDA, the agency required Philips to submit a plan to repair, replace or refund the affected devices. The agreement also barred Philips from manufacturing or selling certain Respironics devices in the U.S.

“We are not in control of any timing around the return to market,” CEO Roy Jakobs said in a Tuesday earnings call. “We keep working towards that so that actually we are ready, but ultimately it needs to be granted by the FDA, and we keep working with them.”

Outside of the U.S., Philips has seen growth with its sleep devices, Jakobs said.

The recent settlement excludes other proceedings, such as an investigation by U.S. state attorneys general, according to the company.

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