According to a news report posted on medtechdive.com, Getinge has initiated a recall of more than 11,000 of its ventilators. The U.S. Food and Drug Administration has categorized the recall as a Class I recall due to the possibility of injury or death. Getinge issued a critical medical device correction alert concerning devices distributed last month after the company discovered an issue that could cause loss of ventilation. If a loss of ventilation occurs, patients could suffer life-threatening circulatory failure. Getinge estimates the odds of one of these devices experiencing this error to be about 0.002%.
The Class I Recall includes four Getinge devices, including the Servo-u mechanical ventilators and Getinge’s Servo-n products for use with neonates. All of the affected medical devices have a problem related to their alarms. Getinge initiated the product recall after it discovered the devices might sound a variety of alarms resulting in a loss of communication, the loss of ventilation, and the triggering of technical alarms. Should a ventilator stop functioning, the patient might breathe too shallowly or too slowly, causing the patient to receive too little oxygen resulting in circulatory failure and/or brain injuries.
Getinge advises patients to follow the existing precautions to minimize the impact of the loss of ventilation, and the company has updated its software platform. Getinge has already issued a field safety notice concerning the devices’ alarm-related issues in Europe last June. In that warning notice, Getinge explained the three scenarios in which ventilation stopped while patients were being treated with Servo-n.
Getinge’s recall follows Philips’ recall of more than 5.5 million sleep apnea, CPAP, BiPAP, and ventilator devices due to toxic sound abatement foam. Lawsuits filed against Philips allege that the company was aware of the risks for several years before it initiated the recall.
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