Philips Reaches Agreement With FDA Over Ventilator Recall

By Elena Vardon

Royal Philips has reached an agreement with the U.S. Food and Drug Administration on the terms of consent decree for its Respironics business operations in the country over the recall of its ventilators.

The Dutch health-technology group on Monday said that it took a 363 million euro ($394 million) provision in the fourth quarter for remediation activities, inventory write-downs and onerous contract provisions linked to addressing this settlement.

"The decree will provide Philips Respironics with a roadmap of defined actions, milestones, and deliverables to demonstrate compliance with regulatory requirements and to restore the business," it said, adding that it will continue to service existing sleep and respiratory care devices as well as supply accessories, consumables, and replacement parts, but won't sell new CPAP or BiPAP sleep therapy devices or other respiratory care devices in the country.

Write to Elena Vardon at elena.vardon@wsj.com

(END) Dow Jones Newswires

January 29, 2024 01:47 ET (06:47 GMT)

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