Philips Respironics devices no longer being sold in US

Philips Respironics will stop selling its sleep therapy and respiratory care devices in the U.S. until it meets the demands of a consent decree from the FDA, according to a press release from the company.

This news comes after FDA recalls in 2023 of Philips Respironics DreamStation devices and V60 Ventilators and V60 Plus Ventilators. In October 2023, the FDA also requested more testing regarding the recall of certain ventilators, bilevel positive airway pressure machines and CPAP machines made by Philips Respironics.

The consent decree has yet to be finalized, but the company announced in the release that it agrees to the terms.

“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,” the press release said.

Although sale of these devices will be halted in the U.S. with this decision, the company said in the release that it will still continue to service them. Philips Respironics will also supply accessories, consumables and replacement parts for devices already in use in the U.S. while working to meet the consent decree.

“Patient safety and quality remain Philips’ highest priority across the company,” Roy Jakobs, MBA, CEO of Royal Philips, said in the release. “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. We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”

This announcement does not impact the sale of devices in areas outside the U.S., the release noted.