Once again, Philips has been hit with an FDA Class I label for a correction to certain of its respiratory support devices.
The latest recall—which represents a voluntary product correction, rather than a full-blown product removal, per an FDA notice Friday—concerns just a few of Philips’ V60 and V60 Plus ventilators. It marks the fifth Class I tag that the Dutch devicemaker’s Respironics division has received this year alone, all of which have rolled in as the company still works its way through repairing and replacing all 5.5 million CPAP and BiPAP machines, ventilators and other devices affected by the still-ongoing June 2021 recall.
The V60 and V60 Plus devices escaped that longstanding recall since they don’t contain the polyester-based polyurethane foam at its heart. The ventilators are used in hospital settings to provide breathing assistance to both adult and pediatric patients.
According to the FDA, some of the V60 and V60 Plus ventilators distributed in May of this year contain a power management printed circuit board assembly that “do not meet ventilators standards.”
The faulty power management circuits, which were distributed by a third-party warehouse, may malfunction and cause a ventilator to lose function or power, which could potentially lead to injuries or deaths if patients aren’t receiving the breathing support they need and aren’t being directly monitored in the hospital.
The recall only affects nine devices in total, eight of which were distributed in the U.S., and no reports of patient injuries or deaths have been linked to the issue.
Philips initiated the recall to begin the correction process at the end of August. At the time, it sent letters to all affected customers asking them to stop using and quarantine the ventilators until they were contacted by a company representative to coordinate a time to remove and/or replace the faulty circuit board assemblies. In a statement sent to Fierce Medtech on Monday, Philips confirmed that all nine ventilators completed remediation in September.
Though the V60 and V60 Plus ventilators remain unscathed by Philips’ much-larger June 2021 respiratory recall, this isn’t the first time they’ve been in the FDA’s crosshairs in recent years.
In August 2021, shortly after that far-reaching CPAP recall began, the V60 and V60 Plus ventilators earned a Class I recall rating of their own, with more than 16,500 devices distributed since May 2009 affected. That time, the recall came about after Philips discovered that a partial blockage of the devices’ breathing circuits could result in a lower oxygen flow than required; as of the August recall notice, the issue had sparked reports of 61 incidents and 25 injuries, and Philips issued a new set of safety guidelines for use of the ventilators.
The next year brought with it two more Class I labels for the devices: One for a recall of about 1,500 devices in the U.S. found to contain an expired adhesive that could lead to damage in the internal capacitors—which wasn’t linked to any reported injuries or deaths, per the March 2022 notice—and the other spanning more than 99,000 V60, V60 Plus and V680 ventilators around the world that were found to be at risk of “silent shutdowns” due to an issue with an internal electrical circuit—and which subsequently sparked complaints of one patient death and four injuries.
Editor's note: This story was updated to include information from Philips' statement on the recall.