American depositary receipts (ADRs) of Koninklijke Philips (PHG) sank in early trading on Friday as the 澳洲幸运5官方开奖结果体彩网:Food and Drug Administration (FDA) ruled the Netherlands-based health tech firm’s handling of✨ a recall of sleep apnea devices was not sufficient.

Philips initiated the recall after U.S. regulators warned in June 2021 that millions of Philips ventilators, BiPAP machines, and CPAP machines were dangerous because poly🍸urethane foam in them to reduce sound could break down and be inhaled or swallowed by people using them. 

The FDA indicated that it does not believe “the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users of the recalled devices.” Officials adde🎃d that additional testing🦂 is needed, and that Philips has agreed to do so.

The company noted that it shared the same objective as the FDA and other regulatory agencies, and it remains committed to work with them as it continues “to dedicate all necessary resources to ensure that patients receive remediated devices, and the test and research program is completed."

Philips and its Philips Respironics unit agreed last month in a Pennsylvania court to pay at least $479 million to compensate those who bought the machines.

Koninklijke Philips ADRs were down 7% as of noon E.T. on Friday following the news, but were over 22% higher for 2023.