Royal Philips has recently reached an agreement with the U.S. Food and Drug Administration (FDA) regarding the recall of its ventilators under its Respironics business operations in the country. This consent decree signifies a significant step toward addressing the issue and ensuring compliance with regulatory requirements.

Taking Actions for Compliance

In response to this development, the Dutch health-technology group has allocated a provision of €363 million ($394 million) in the fourth quarter. This provision will be utilized for various remediation activities, inventory write-downs, and onerous contract provisions related to resolving the matter at hand.

A Clear Path Ahead

Under the terms of the agreement, Philips Respironics will adhere to a predefined roadmap consisting of specified actions, milestones, and deliverables. This process will not only demonstrate compliance with regulatory requirements but also facilitate the restoration of the business.

Continued Support for Existing Devices

While the company focuses on addressing the mentioned concerns, Philips assures its customers that it will continue to provide service for existing sleep and respiratory care devices. This includes supplying accessories, consumables, and replacement parts. However, the sale of new CPAP or BiPAP sleep therapy devices, as well as other respiratory care devices, will be temporarily discontinued in the country.

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