Servo-u (ventilator)

2022: Getinge recalls thousands of defective ventilators causing circulatory problems

On August 24, 2022, Getinge announced the recall of more than 37,000 ventilators, consisting of four models of the company's range of devices, including a Servo-u mechanical ventilator and a Servo-n device designed to care for newborns. All devices suffer from an alert system problem.

Getinge has started a recall as devices can generate whole combinations of warning messages that can cause communications to fail, alarms to fire, and ventilation to stop. If the ventilator stops working, the patient begins to breathe too slowly or inhale insufficient air, as a result of which the necessary amount of oxygen does not enter his blood, which can lead to traumatic brain injuries and impaired blood circulation.

Servo-u (ventilator)

As a result of the malfunction, which affects 11,089 ventilators in the United States and 37 thousand devices around the world, Getinge recommends that users adhere to existing precautions that will minimize the consequences of stopping ventilation, and has updated its software platform.

In June 2022, Getinge sent out a notification about problems with the alert system related to the same devices in Europe. In that notice, the company described three instances of mechanical ventilation being stopped while the Servo-n device was running. Getinge estimated the probability of a malfunction in each individual device as less than 0.002%.

The recall comes amid attempts by Philips to repair or replace more than 5.5 million sleep apnea devices and ventilators amid concerns about the risks associated with sound-absorbing foam. The latest lawsuit alleges Philips was aware of the risks for several years before the recall began.^[1]

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