Class I Recall of GE Healthcare Aestiva/5 7900 Ventilator
Published: Jul 11, 2012
The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals of a Class I Recall of the GE Healthcare Aestiva/5 7900 Ventilator. There is a potential for two vaporizers to deliver each agent at the same time. This could result in over-delivery of a single agent if both vaporizers contain the same agent, or in delivery of more than one agent. Unrecognized overdose with simultaneous inhaled anesthetics is manifested by hypotension, arrhythmia and bradycardia that, if persists and remains unrecognized, may lead to circulatory shock. This ventilator may cause serious adverse health consequences, including death.
See the Recall Notice for a listing of affected Serial Numbers.
Want to read the full alert and receive alert emails?