Philips provides update on earlier announced voluntary CPAP, BiPAP and Mechanical Ventilator recall notification*
November 14 2021 - 5:00AM
November 14, 2021
Amsterdam, the Netherlands – On June 14, 2021,
Royal Philips’ (NYSE: PHG, AEX: PHIA) 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 US Food and Drug Administration (FDA) recently
conducted an inspection of a Philips Respironics manufacturing
facility in connection with the recall. On November 12, 2021, the
FDA published a list of the observations it provided to Philips
Respironics. 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 connection with the voluntary recall notification in June of
this year, the FDA has recently conducted an inspection of a
Philips Respironics manufacturing facility in the US,” said Frans
van Houten, CEO of Royal Philips. “We will work closely with the
FDA to clarify and follow up on the inspectional findings and its
recent requests related to comprehensive testing. Until we have
concluded these discussions, we are not able to publicly provide
further details on these responses. We remain fully committed to
supporting the community of patients who rely on the affected
devices, and the physicians and customers who are dedicated to
meeting patient needs.”
Since June 2021, Philips Respironics and certified testing
laboratories have been conducting a comprehensive test and
research program on the PE-PUR foam to better assess and scope
potential patient health risks, with support from appropriately
qualified third-party experts. 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 acceptable results. Philips
Respironics continues to coordinate with the FDA and other
competent authorities on its testing.
An FAQ is available here.
* Voluntary recall notification in the US/field safety notice
outside the US
For further information, please
contact:
Steve KlinkPhilips Global Press OfficeTel.: +31 6
10888824E-mail: steve.klink@philips.com
Derya GuzelPhilips Investor RelationsTel.: +31 20 59
77055E-mail: derya.guzel@philips.com
About Royal PhilipsRoyal 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,
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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.
This press release contains inside information within the
meaning of Article 7(1) of the EU Market Abuse Regulation.
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