Philips' ventilator woes drag on with yet another Class I recall

Though Philips recently expanded its ongoing respiratory device recall to include around 5.2 million machines, that list left off a handful of ventilators that weren’t affected by the original issue. Unfortunately, in the months since the recall began last June, several of those devices have become the subject of unrelated safety events of their own.

Among these are the company’s V60 and V60 Plus ventilators for high-flow oxygen therapy, which have now sparked two separate Class I recalls since last summer.

The latest was initiated by Philips at the end of January and given the FDA’s most serious classification this week. It concerns just over 1,500 of the machines that were distributed in the U.S. in the two weeks between July 29 and August 11 of last year.

The V60 and V60 Plus devices are used in clinical settings to provide mechanical breathing support to patients who can still breathe on their own. They’re indicated for patients who have been hospitalized with conditions like respiratory failure, chronic respiratory insufficiency or obstructive sleep apnea, including adults and children weighing at least 20 kilograms.

According to the FDA’s notice, the recall stems from the use of an expired adhesive in the affected ventilators. The outdated material may be less effective at holding parts of the device together, potentially causing damage to those parts if they come loose.

The notice specifically cites damage to the internal capacitors. If they’re damaged, the machine could stop providing ventilation to a patient—with or without sounding an alarm. It’s a dangerous situation either way, the FDA said, because even if an alarm sounds, the time it takes to connect a new device without intermediate breathing support could have severe health effects similar to those that may occur if the device stops providing support without alerting the healthcare provider.

So far, neither the regulator nor Philips has received any reports of injuries, adverse health effects or deaths linked to the expired adhesive.

Distributors and buyers of the ventilators can continue to use the affected devices. However, they’re advised to connect each machine to a remote alarm system and set up external oxygen monitoring so they can catch device failure as quickly as possible, and to “always have immediate access to an alternative means of ventilation.”

If failure does occur, healthcare providers should immediately hand over breathing support to another device and contact their Philips customer service representative to schedule a repair.

The Class I recall came about half a year after another for the V60 and V60 Plus devices. That case—which was initiated in June and labeled by the FDA in August—spanned more than a decade’s worth of machines, totaling 16,535 ventilators distributed in the U.S. between May 2009 and mid-2021.

The devices were found to be at risk of providing a lower oxygen flow rate than needed if the airflow is blocked for any reason, causing the system pressure to reach its default maximum limit.

At the time, a total of 25 injuries and more than 61 other incidents had been reported in connection with the system flaw, with no deaths reported.