FDA Provides Update on Philips Respironics’ Recall of its V60 and V60 Plus Ventilators

The FDA has issued on update on Philips Respironics’ Jan. 24 recall of its V60 and V60 Plus ventilators, deeming it a Class 1 recall because of the risk of serious injury or death.

Some of the devices had parts that were put together using an expired adhesive, the agency said. And if the adhesive fails, it could cause a capacitor support bracket to come loose and damage the capacitors, which could cause the ventilator to stop working.

This would usually trigger an alarm. But if the alarm also fails, a patient could be deprived of oxygen for an extended time, the FDA said.

The 1,511 affected products were distributed from July 29 to Aug. 11, 2021. There have been no reported injuries or deaths so far, the agency said.