Philips piles on another trio of Class I recalls for beleaguered ventilator portfolio

There seems to be no limit to Philips’ ventilator safety woes. Nearly a full year after initiating a recall of many of its respiratory devices that has since stretched to encompass around 5.2 million machines distributed around the world, the company continues to accumulate safety notices for those and other devices in its vast Respironics portfolio.

The latest safety event concerns the V60, V60 Plus and V680 ventilators. Though all three models escaped the original far-reaching recall, about 1,500 of the V60 and V60 Plus machines were the target of yet another FDA notice earlier this year.

This time around, the trio of ventilators are the subject of a total recall, spanning at least 99,000 devices distributed across the U.S. and around the world. As of this week, the FDA has issued its most serious Class I rating to the safety notices for all three models.

The V60 and V60 Plus ventilators have been cleared by the FDA to provide high-flow oxygen therapy and noninvasive ventilation in healthcare facilities, while the V680 device is designed to offer both invasive and noninvasive ventilation to critically ill patients in the intensive care unit and has yet to be cleared in the U.S.

The safety events for all three systems stem from an issue with an internal electrical circuit that's linked to the power supply for the ventilators and their alarms. Philips said the issue may cause affected units to stop working, potentially without alerting healthcare providers to the malfunction. The company projected that the issue will cause an average of less than one “silent shutdown” for every million uses per year.

The issue spans all lots and serial numbers of the devices, including more than 87,000 V60 ventilators, 12,000 V60 Plus units and an undisclosed number of V680 machines that have been sold in more than 100 countries.

Philips initiated the trio of recalls at the end of February and issued an urgent medical device correction to all affected customers in mid-March. In it, the company advised healthcare providers not to stop using the ventilators but to have a backup ventilation system at the ready.

The Dutch devicemaker is also asking users to take at least one of several mitigating actions, all in an effort to ensure the devices are working normally and to be able to identify a malfunction as soon as it occurs. They can connect the machines to a nurse call/remote alarm system that can “provide a backup signal to the clinician even if the ventilator’s primary alarm system does not activate”; install an oxygen analyzer or monitor; or take regular pulse oximetry readings from patients.

“We are committed to providing products and solutions that are safe and reliable for those who depend on them. 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,” David Ferguson, the business leader of Philips Respironics, said in a statement sent to Fierce Medtech.

Neither Philips nor the FDA’s database entries specified whether the issue has been linked to any injuries, complaints or other adverse events. The company said it is developing a plan to address the potential malfunction, with the first public update on that plan due by the end of June.

Just last month, the FDA dished out another Class I label to a smaller recall of the V60 and V60 Plus devices. That recall affected about 1,500 machines distributed in the U.S. during a two-week period in July and August of 2021, thanks to the accidental use of expired and therefore potentially ineffective adhesive to hold some internal parts together. No injuries were reported in conjunction with the mistake.

Before that, in the summer of 2021, the two models came under scrutiny again. That time, the Class I recall spanned more than 16,500 V60 and V60 Plus ventilators that had been found to be at risk of providing a lower oxygen flow rate than needed if the airflow was blocked in any way. About two dozen injuries and more than 60 other incidents were linked to the issue.

Editor's note: This article has been updated with additional information about the recalls and a statement from Philips.