Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certa...
14 Giugno 2021 - 07:00AM
Philips issues recall notification* to mitigate potential health
risks related to the sound abatement foam component in certain
sleep and respiratory care devices
June 14, 2021
- Philips is initiating a voluntary recall notification* to
ensure patient safety in consultation with regulatory agencies
- Corrective actions include the deployment of updated
instructions for use and a repair and replacement program for
affected devices
- Philips aims to address all affected devices within the scope
of this correction as expeditiously as possible
Amsterdam, the Netherlands – Following the
company update on April 26, 2021, Royal Philips (NYSE: PHG; AEX:
PHIA) today provides an update on the recall notification* for
specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP),
Continuous Positive Airway Pressure (CPAP), and mechanical
ventilator devices to address identified potential health risks
related to the polyester-based polyurethane (PE-PUR) sound
abatement foam component in these devices. The majority of the
affected devices within the advised 5-year service life are in the
first-generation DreamStation product family.
To date, Philips has produced millions of Bi-Level PAP, CPAP and
mechanical ventilator devices using the PE-PUR sound abatement
foam. Despite a low complaint rate (0.03% in 2020), Philips
determined based on testing that there are possible risks to users
related to this type of foam. The risks include that the PE-PUR
foam may degrade into particles which may enter the device’s air
pathway and be ingested or inhaled by the user, and the foam may
off-gas certain chemicals. The foam degradation may be exacerbated
by use of unapproved cleaning methods, such as ozone,** and high
heat and high humidity environments may also contribute to foam
degradation.
Therefore, Philips has decided to voluntarily issue a recall
notification* to inform patients and customers of potential impacts
on patient health and clinical use related to this issue, as well
as instructions on actions to be taken.
“We deeply regret any concern and inconvenience that patients
using the affected devices will experience because of the proactive
measures we are announcing today to ensure patient safety,” said
Frans van Houten, CEO of Royal Philips. “In consultation with the
relevant regulatory agencies and in close collaboration with our
customers and partners, we are working hard towards a resolution,
which includes the deployment of the updated instructions for use
and a comprehensive repair and replacement program for the affected
devices. Patient safety is at the heart of everything we do at
Philips.”
Recall notification* advise for patients and
customersBased on the latest analysis of potential health
risks and out of an abundance of caution, the recall notification*
advises patients and customers to take the following actions:
- For patients using affected
BiLevel PAP and CPAP devices: Discontinue use of
your device and work with your physician or Durable Medical
Equipment (DME) provider to determine the most appropriate options
for continued treatment. To continue use of your device due to lack
of alternatives, consult with your physician to determine if the
benefit of continuing therapy with your device outweighs the risks
identified in the recall notification.*
- For patients using affected
life-sustaining mechanical ventilator devices: Do
not stop or alter your prescribed therapy until you have talked to
your physician. Philips recognizes that alternate ventilator
options for therapy may not exist or may be severely limited for
patients who require a ventilator for life-sustaining therapy, or
in cases where therapy disruption is unacceptable. In these
situations, and at the discretion of the treating clinical team,
the benefit of continued usage of these ventilator devices may
outweigh the risks identified in the recall notification.*
Possible health risksThe company continues to
monitor reports of potential safety issues as required by medical
device regulations and laws in the markets in which it operates. To
date, there have been no reports of death as a result of these
issues. Philips has received reports of possible patient impact due
to foam degradation. The potential risks of particulate
exposure include headache, irritation, inflammation, respiratory
issues, and possible toxic and carcinogenic effects. The
potential risks of chemical exposure due to off-gassing include
headache, irritation, hypersensitivity, nausea/vomiting, and
possible toxic and carcinogenic effects. Philips has received
no reports regarding patient impact related to chemical
emissions.
Repair and replacement programPhilips is
providing the relevant regulatory agencies with required
information related to the launch and implementation of the
projected correction. The company will replace the current sound
abatement foam with a new material and has already begun the
preparations, which include obtaining the relevant regulatory
clearances. Philips aims to address all affected devices in scope
of this correction as expeditiously as possible.
As part of the program, the first-generation DreamStation
product families will be modified with a different sound abatement
foam and shipped upon receipt of the required regulatory
clearances. Philips’ recently launched next-generation CPAP
platform, DreamStation 2, is not affected by the issue. To support
the program, Philips is increasing the production of its
DreamStation 2 CPAP devices, that are available in the US and
selected countries in Europe.
FinancialsIn terms of the financial impact,
Philips anticipates that the expected revenue headwinds in the
Sleep & Respiratory Care business in 2021 will be compensated
by the strength of the company’s other businesses. Therefore, the
full year comparable sales growth and Adjusted EBITA margin
guidance provided on April 26, 2021 remains unchanged.
The updated instructions for use of the affected devices have
resulted in adjustments to and acceleration of the repair and
replacement program, as well as intensified communication with
customers and patients. This had led to an increase of EUR 250
million in the expected costs of the corrective actions on the
installed base, in addition to the provision that the company
recorded in the first quarter of 2021.
Additional informationFor more information on
the recall notification,* as well as instructions for customers,
users and physicians, affected parties may contact their local
Philips representative or visit www.philips.com/SRC-update.
* This is a recall notification for the
US only, and a field safety notice for the rest of the
world** Potential Risks Associated With The Use of
Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP
Machines and Accessories: FDA Safety Communication.
For media and investor questions, please
contact:
Steve KlinkPhilips Global Press OfficeTel.: +31 6
10888824E-mail: steve.klink@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 2020 sales of EUR 17.3 billion and
employs approximately 77,000 employees with sales and services in
more than 100 countries. News about Philips can be found at
www.philips.com/newscenter.
Forward-looking statementsThis 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.
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