The U.S. Food and Drug Administration (FDA) announced that the HAMILTON-T1 ventilators with software versions 1.1.2 and lower have been recalled due to a risk of serious injury and death. The HAMILTON-T1 ventilator gives adults and pediatric patients continuous breathing support.
According to the FDA, the devices were recalled because small pediatric patients with high airway resistance and low lung function may receive too much oxygen when using the ventilators. This can result in a miscalculation of oxygen, which can result in serious health risks and death.
Hamilton Medical altered their customers of the problem in a letter on Jan. 11. In the letter, the company informed them that it was working on a solution to the problem. The company told customers to update the T1 Operator Manuals with an included Oxygen Consumption formula page that provides a loaner unit while their ventilator is being updated.
The HAMILTON-T1 is designed to ventilate pediatric and adult ICU patients at any place around the world. It is very compact, with a size of less than 6.5 kg. The ventilator is used in mobile ICU ambulances, helicopters, long distance ambulance jets, during intra-hospital transports, in the ICU and in emergency departments.
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