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Royal Philips' Subsidiaries Plan to Complete Remediation of Sleep, Respiratory Devices Following Deal With FDA
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Royal Philips' Subsidiaries Plan to Complete Remediation of Sleep, Respiratory Devices Following Deal With FDA
Apr 10, 2024 1:48 AM

04:25 AM EDT, 04/10/2024 (MT Newswires) -- Royal Philips (PHG) said early Wednesday that its subsidiary, Philips Respironics, will continue to prioritize completing the remediation of the sleep and respiratory care devices under the unit's voluntary June 2021 recall.

The announcement comes as the company's subsidiaries -- Philips Holding USA and Philips Respironics -- reached a final agreement on the consent decree with the US Department of Justice and the US Food and Drug Administration.

The decree primarily focuses on Philips Respironics' business operations in the US, a statement from the company said. "It provides clarity and a roadmap to demonstrate compliance with regulatory requirements and to restore the Philips Respironics business."

The company said Philips Respironics is "committed to meeting the consent decree requirements while continuing to service healthcare providers and their patients under agreed conditions in the US and outside the US."

Further, the 2023-25 financial outlook for the group takes the decree into account and "remains unchanged."

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