TECH - Dutch Health Tech Firm Philips Stops US Sales Of Respiratory Devices Under Finalized Consent Decree Over Device Recall | Benzinga
In its Q4 earnings release on Monday, Koninklijke Philips NV (NYSE:PHG) agreed on a settlement with the FDA, primarily focusing on Philips Respironics’ business operations in the U.S.
Philips Respironics is finalizing a consent decree, which will be presented to a U.S. court for approval.
The decree outlines specific actions, milestones, and deliverables for Philips Respironics to demonstrate compliance with regulatory requirements and revive its business.
In November, the FDA warned patients and healthcare providers to carefully monitor Philips’ DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating.
In the U.S., Philips Respironics will continue servicing existing sleep and respiratory care devices for healthcare providers and patients, supplying accessories, consumables, and replacement parts.
However, the company will not sell new ...