In its Q4 financial results, Philips announced that it would stop selling Philips Respironics CPAP or BiPAP sleep therapy devices or other respiratory care devices in the U.S. as part of a consent decree it signed with the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration.
The consent decree is being finalized and will provide Philips Respironics with a roadmap of defined actions, milestones, and deliverables to demonstrate compliance with regulatory requirements and to restore the business, according to the company.
In the U.S., Philips Respironics will still continue to service sleep and respiratory care devices already with healthcare providers and patients, and supply accessories (including patient interfaces), consumables (including patient circuits), and replacement parts (including repair kits).
Outside the US, Philips Respironics will continue to provide new sleep and respiratory care devices, accessories, consumables, replacement parts and services, subject to certain requirements.
“Patient safety and quality remain Philips’ highest priority across the company. Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologize for the distress and concern caused,” said Roy Jakobs, CEO of Royal Philips. “We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”
Philips Respironics issued a recall of its ventilators, BiPAP machines, and CPAP machines in 2023 and in 2021 for issues with material components of its respiratory products that had the potential to cause harm to patients.
The ongoing recall issues with Philips products have also become embroiled in a congressional battle to review the strength and effectiveness of the FDA’s medical device oversight. It was found that despite reports of issues with certain Philips devices dating back to 2010, the issue wasn’t reported to the FDA until a decade later.
Photo courtesy of Philips