FDA lifts injunction on manufacture and distribution of Philips’ defibrillators in the US
April 24 2020 - 2:53AM
April 24, 2020
Amsterdam, the Netherlands – Royal Philips
(NYSE: PHG, AEX: PHIA), a global leader in health technology,
announced today that its Emergency Care and Resuscitation (ECR)
business is resuming manufacturing and shipping of external
defibrillators for the US, following notification from the US Food
and Drug Administration (FDA) that the injunction prohibiting those
activities has been lifted.
This business has been operating under a consent decree with the
FDA since November 2017. Under the terms of the consent decree,
Philips was required to suspend manufacture and distribution of its
defibrillators from specific Philips facilities in the U.S.,
pending FDA certification via inspection of the facilities’
compliance with Quality System Regulation. However, in order to
ensure uninterrupted availability of these life-saving devices in
the US, the consent decree included exemptions for specific Philips
Automated External Defribrillator (AED) models to continue to be
manufactured and shipped, in addition to providing necessary device
servicing, accessories and consumables.
Philips continues to comply with the terms of the consent
decree, which remains in effect, and includes ongoing regulatory
compliance monitoring and facility inspections of the ECR business
and of Philips’ other patient care businesses by the FDA.
“The injunction lift is an important milestone for Philips, as
we have enhanced the regulatory compliance processes in our ECR
business and throughout the company,” said Frans van Houten, CEO of
Royal Philips. “Providing our customers with safe and reliable
products and solutions remains our highest priority, and I am proud
that our AEDs save lives daily, with their very high reliability
record.”
For further information, please
contact:
Ben ZwirsPhilips Global Press OfficeTel.: +31 6 15213446E-mail:
ben.zwirs@philips.com
Leandro MazzoniPhilips Investor RelationsTel.: +31 20 59
77222E-mail: leandro.mazzoni@philips.com
About Royal PhilipsRoyal Philips (NYSE: PHG,
AEX: PHIA) is a leading health technology company focused on
improving people's health 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 2019 sales of EUR 19.5 billion and
employs approximately 81,000 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 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.
This press release contains inside information within the
meaning of Article 7(1) of the EU Market Abuse Regulation.
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