Philips Respironics Issues Voluntary Recall Notification/Field Safety Notice* for the V60 Ventilator Product Family

Summary

Company Announcement

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.

About Royal Philips

Royal 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 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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.