Philips provides update on the test and research program in connection with the CPAP, BiPAP and Mechanical Ventilator recall notification*
23 Dezembro 2021 - 04:00AM
Philips provides update on the test and research program in
connection with the CPAP, BiPAP and Mechanical Ventilator recall
notification*
December 23, 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 potential health
risks related to the polyester-based polyurethane (PE-PUR) sound
abatement foam in these devices. Since then, together with
certified testing laboratories and other qualified third-party
experts, Philips Respironics has been conducting a comprehensive
test and research program on the PE-PUR foam to better assess and
scope potential patient health risks related to possible emission
of particulates from degraded foam and certain volatile organic
compounds (VOCs). Philips Respironics is now providing an update on
part of this test and research program. Specifically, this update
covers the test results and
assessment to date of the
VOC emissions of the first-generation
DreamStation devices. The
first-generation DreamStation devices represent the majority of the
registered affected devices. Additional testing is ongoing.**
Review of this assessment by an outside medical panel and
Philips Respironics has determined that exposure to the
level of VOCs identified to date
for the first-generation
DreamStation devices
is not typically
anticipated to result in long-term health consequences for
patients.
The update on these findings is intended to inform healthcare
providers of the most recent data, but the overall guidance for
physicians and patients in the recall notification remains
unchanged at this time.
At the time the recall notification was issued, Philips
Respironics relied on an initial, limited data set and
toxicological risk assessment. Since then, using ISO 18562
guidance, VOC toxicological risk assessments were performed by
certified testing laboratories and a qualified third-party expert
based on the initial and new VOC testing performed to date. Philips
Respironics has made this data available to the FDA and other
competent authorities and is in the process of sharing this data
with healthcare providers and patients.
It is important to note that the tested DreamStation devices
were not exposed to ozone cleaning, in accordance with the
instructions for use. Additionally, this new assessment is limited
to the evaluation of VOCs for first-generation DreamStation
devices, and does not evaluate the risks of potential foam
particulates or cover other devices affected by the recall. Further
health risk assessments are ongoing.**
Comprehensive particulate testing and analyses are now expected
to be completed in the second quarter of 2022, as testing protocols
in compliance with the full extent of the relevant ISO standards
for all affected product platforms require long lead times of
multiple months. Philips Respironics will continue to provide
updates on findings from these assessments.
Additional informationFor more information on
the recall notification,* as well as instructions for customers,
patients and physicians, affected parties may contact their local
Philips representative or visit www.philips.com/SRC-update. The
content of this press release is intended to inform healthcare
providers of the most recent data, but the overall guidance for
physicians and patients in the recall notification remains
unchanged at this time.
* Voluntary recall notification in the U.S. / field
safety notice outside the U.S.** The ongoing test and the research
program includes: Assessment of the health risks associated with
VOC emission of the CPAP, BiPAP and Mechanical Ventilator devices
affected by the recall notification; assessment of the health risks
associated with possible degraded foam particulates for all
affected devices; assessment of the health risks associated with
exposure of the devices to repeated ozone cleaning.
For further media
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,
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.
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