The U.S. Food and Drug Administration on Tuesday classified the recent recall of some of Philips’ ventilators as Class 1, or the most serious type of recall, saying the use of these devices may cause serious injuries or death.
This is the second Class 1 recall initiated by the company this year.
In June, the Dutch medical equipment company also recalled some of its breathing devices and ventilators, as the foam used to dampen the machines’ sound could degrade and emit small particles that irritate airways.
The FDA said on Tuesday there have been 61 incidents and 25 injuries through the products recalled recently, but no deaths were reported for these issues.
The company initiated the second recall also in June and has so far recalled 16,535 devices in the United States.
Philips has recalled the V60 and V60 Plus ventilators, as there is a risk of patients receiving reduced oxygen in certain situations which could lead to adverse events.
The devices have a design safety mechanism that limits the amount of oxygen flow in situations where the system pressure reaches a default maximum pressure limit, due to a partial obstruction in the breathing circuit, according to the FDA.