Getinge is recalling several different types of ventilators in its device portfolio that are being labeled as a Class I event, which is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
The recall covers four devices in Getinge’s portfolio, including the Servo-u mechanical ventilator and the Servo-n product designed for use with neonates. All of the devices suffer from an issue related to their alarms.
Getinge began the recall because the devices may generate a combination of alarms that can result in a loss of communication, the triggering of technical alarms and loss of ventilation. If a ventilator stops working, the patient may breathe too slowly or shallowly and therefore get too little oxygen into their blood, which could result in brain injuries and circulatory failure.
In response to the fault, which affects 11,089 ventilators in the U.S. and 37,000 products worldwide, Getinge is advising users to adhere to existing precautions that would minimize the impact of the loss of ventilation and has updated its software platform.
Read the full article at MedTech Dive.
