Switzerland-based Hamilton Medical recalled 21,429 ventilators distributed in the U.S. because they might power off unexpectedly, the FDA said Aug. 30.
If the company's C1, C2, C3 and T1 ventilators are used for more than 91 days without restarting, they pose a risk of switching to an "Ambient State." The FDA classified the recall as Class I, the most serious type, because the problem could result in serious injury or death.
As of Aug. 30, Hamilton has reported 80 complaints and zero injuries or deaths related to the recall.
Healthcare professionals are instructed to provide alternative ventilation immediately.