FDA classifies Resmed Astral ventilator correction as Class I after five serious injuries
The United States Food and Drug Administration (FDA) has classified Resmed Ltd.’s correction of certain Astral 100 and Astral 150 ventilators as a Class I recall after a leaking internal component was linked to five serious injuries and the potential for ventilation therapy to stop without warning. The action covers 168,069 devices distributed worldwide and