Philips confirms that further to communicating the main terms of the
- The consent decree primarily focuses on Philips Respironics’ business operations in the US.
- It provides clarity and a roadmap to demonstrate compliance with regulatory requirements and to restore the
Philips Respironics business. 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.- The 2023 – 2025 Group financial outlook takes the consent decree into account and remains unchanged.
Philips’ subsidiaries
The consent decree provides
Philips Respironics will continue to prioritize completing the remediation of the sleep and respiratory care devices under Respironics’ voluntaryJune 2021 recall. More than 99% of the actionable registered CPAP and BiPAP sleep therapy devices have been remediated globally, while the remediation of the ventilators is ongoing in coordination with the relevant competent authorities.Philips Respironics will retain independent experts to review various aspects of the recall remediation.
- Philips Respironics’ business operations must demonstrate continued compliance with the FDA’s Quality System Regulation (current good manufacturing practice requirements for medical devices).
Philips Respironics will retain independent experts to supervise the compliance improvement program.
- In the US, millions of patients are currently using
Philips Respironics sleep and respiratory care devices.Philips Respironics will be permitted to continue servicing these sleep and respiratory care devices that are already with healthcare providers and patients, and to sell accessories (including masks), consumables (including patient circuits), and replacement parts (including repair kits).
- In 2021,
Philips Respironics voluntarily stopped selling CPAP and BiPAP sleep therapy devices and other respiratory care devices in the US, as it prioritized the production for the remediation of the affected devices under theJune 2021 recall. Until the relevant requirements of the consent decree are met,Philips Respironics will not resume selling new CPAP or BiPAP devices or other respiratory care devices in the US.
- The consent decree includes provisions to allow for exports. Outside the US,
Philips Respironics will continue to provide new sleep and respiratory care devices, accessories (including masks), consumables (including patient circuits), replacement parts (including repair kits) and services, subject to certain requirements thatPhilips Respironics will meet.
Philips Respironics’ devices with the new silicone sound abatement foam have been subject to extensive testing in accordance with the applicable industry testing standards, and
Philips Chief Patient Safety and Quality Officer Steve C de Baca said: “Patient safety and quality is our number one priority. We know what we must do to meet the consent decree requirements.
Financial impact
As previously stated on
The previously stated 2023-2025 Group financial outlook of mid-single-digit comparable sales growth, low-teens Adjusted EBITA margin, and
General information about this consent decree can be found here. Further information about this consent decree for investors and financial analysts can be found here and here.
For further information, please contact:
Philips External Relations
Tel.: +31 6 1088 8824
E-mail: steve.klink@philips.com
Philips Investor Relations
Tel.: +31 20 5977055
E-mail: leandro.mazzoni@philips.com
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in
Forward-looking statements
This release contains certain forward-looking statements with respect to the financial condition, results of operations and business of Philips and certain of the plans and objectives of Philips with respect to these items. Examples of forward-looking statements include statements made about the strategy, estimates of sales growth, future EBITA, future developments in Philips’ organic business and the completion of acquisitions and divestments. By their nature, these statements involve risk and uncertainty because they relate to future events and circumstances and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these statements.
Source: Royal Philips
2024 GlobeNewswire, Inc., source