Philips creates 'clear path forward' with FDA over Respironics probe

The company said the agreement with the Department of Justice and Food and Drug Administration, which restricts the manufacture and sale of certain sleep therapy and respiratory devices, "provides clarity and a roadmap to demonstrate compliance with regulatory requirements and to restore the Philips Respironics business".

Respironics initiated a voluntary recall "of significant scale" in June 2021 after finding that the soundproofing foam used in certain devices might degrade into particles that could be ingested or inhaled by users. According to FDA data, more than 15m devices were recalled altogether.

In a statement on Wednesday, Philips said that more than 99% of registered Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) devices have been remediated, but the remediation of ventilators is ongoing.

Philips must now prove it can comply with the FDA's manufacturing practice requirements via the Quality System Regulation.

"Until the relevant requirements of the consent decree are met, Philips Respironics will not resume selling new CPAP or BiPAP devices or other respiratory care devices in the US," the company said, after having stopped selling the devices in 2021.

“Strengthening patient safety and quality remains Philips’ highest priority and the increased scrutiny will help us to improve even more," said Philips chief executive Roy Jakobs.

"With the agreement on a consent decree for Philips Respironics in place, we now have a clear path forward to gradually restore the business, serving patients around the world.”

Koninklijke Philips shares were up nearly 3% at €19.61 by 1127 CEST.