Philips Respironics issues voluntary recall notification/field safety notice* for the V60 ventilator product family
April 22 2022 - 11:00AM
April 22, 2022
Amsterdam, the Netherlands – Royal Philips
(NYSE: PHG, AEX: PHIA), a global leader in health technology, today
announced that its subsidiary Philips Respironics is notifying
customers of its V60/V60 Plus and V680 ventilators about a
potential issue with the electrical circuit in these ventilators
that controls the 35V power supply to the ventilator and alarm.
Philips Respironics has already notified the relevant competent
authorities.
Philips Respironics has identified that there is a possibility
that affected ventilator units may cease to operate, potentially
without setting off an audible/visual alarm (a so-called silent
shutdown), and the patient may no longer receive respiratory
assistance. Philips Respironics projects an average of less than
one silent shutdown among one million uses per year.
Philips Respironics is advising customers that they must
implement one or more of the following actions to mitigate
the rare possibility of the hazard caused by the 35V electric
circuit issue:
- Implement an oxygen analyzer with appropriate alarm settings
for each V60/V60 Plus, or V680; and/or
- Connect the V60/V60 Plus or V680 to a nurse call/remote alarm
system, as documented in the instructions for use; upon request,
Philips Respironics can provide technical assistance to implement
this nurse call/remote alarm capability; and/or
- Monitor the patient with pulse oximetry or other physiological
monitoring appropriate to the institution’s capabilities and
patient needs.
Additionally:
- An alternative means of ventilation should be available
whenever the V60/V60 Plus or V680 ventilator is in use. If a fault
is detected in the ventilator, disconnect the patient from it and
immediately start ventilation with such an alternative device. The
ventilator must be removed from clinical use and serviced by
authorized service personnel.
If these mitigations are not available, Philips Respironics
recommends each institution deliberately make a decision that
balances the risks and benefits of continued use of the V60/V60
Plus and V680 against the risks and benefits of ceasing use and/or
substituting other ventilators. Such decision-making should
consider the institution’s capabilities and patient needs.
“We are committed to providing products and solutions that are
safe and reliable for those who depend on them,” said David
Ferguson, Business Leader of Philips Respironics. “The V60
ventilator has been in service for more than 10 years with a high
record of reliability. We take every customer complaint seriously,
and whenever we identify an issue, we address it thoroughly and
transparently in consultation with the relevant competent
authorities. We have created a dedicated team that is focused on
addressing the current issue and providing technical assistance
where needed.”
Philips Respironics is committed to addressing the issue and
will provide regular updates to customers on the development of its
plan to address the issue, with the first update to be provided
before June 30, 2022.
The V60/V60 Plus is not a life support ventilator. It is an
assist ventilator and is intended to augment patient breathing. The
V680 ventilator provides invasive and non-invasive respiratory
support. The V60/V60 Plus and V680 ventilators are not authorized
for use in a home or non-institutional setting.
In connection with this recall notification/field safety
notice,* Philips has taken a provision in the fourth quarter of
2021.
* This is a voluntary recall notification for the U.S.
only, and a field safety notice for the rest of the world. In the
US, the FDA has classified the recall notification as a Class 1
recall.
For further information, please contact:
Steve KlinkPhilips Global Press OfficeTel.: +31 6
10888824E-mail: steve.klink@philips.com
Mario FantePhilips Global Press OfficeTel.: +1 603 560
9226E-mail: mario.fante@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 2021
sales of EUR 17.2 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 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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