Royal Philips NV
Royal Philips NV
11/13/2021 | Press release | Distributed by Public on 11/13/2021 04:31
Philips provides update on earlier announced voluntary CPAP, BiPAP and Mechanical Ventilator recall notification
Nov 13, 2021
Philips provides update on earlier announced voluntary CPAP, BiPAP and Mechanical Ventilator recall notification*
Amsterdam, the Netherlands - On June 14, 2021, Royal Philips' subsidiary Philips Respironics initiated a voluntary recall notification* for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Following the substantial ramp-up of its production, service and repair capacity, the repair and replacement program in the US and several other markets is under way.
As expected, the FDA recently conducted an inspection of a Philips Respironics manufacturing facility in connection with the recall. The FDA provided a list of their observations to Philips Respironics, and in accordance with normal practice, Philips Respironics will submit its response to the inspectional findings for review by the FDA. Importantly, an FDA investigator's list of inspection observations does not constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. Additionally, the FDA has not changed its recommendation to patients and healthcare providers in relation to affected devices.
In June 2021, Philips Respironics initiated a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks, and is getting third-party expert assessments on this. Philips Respironics plans to make more data available to the relevant competent authorities as soon as possible after completing the assessment of the above mentioned research and tests, which is anticipated to take place in the fourth quarter.
Separately, Philips Respironics has conducted testing to support the new silicone replacement foam. Silicone foam testing provided by Philips Respironics to the FDA on devices authorized for marketing in the US had demonstrated adequate results. Philips Respironics continues to coordinate with FDA and other competent authorities on its testing.
Philips is committed to supporting the community of patients who rely on these devices, and the physicians and customers who are dedicated to meeting patient needs.
* Voluntary recall notification in the US/field safety notice outside the US
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum - from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 17.3 billion and employs approximately 78,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
Forward-looking statements
This statement 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.