GE Healthcare Aisys and Avance Anesthesia Systems: Recall
MedSun: Newsletter #49, June 2010
FDA MedWatch Safety Alert
GE and FDA notified healthcare professionals of a Class I Recall of specific lots of the Aisys and Avance Anesthesia Systems. The control board wiring harnesses have a defect which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
Additional Information:
FDA MedWatch Safety Alert. GE Healthcare Aisys and Avance Anesthesia Systems: Recall. May 12, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211918.htm