Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action
MedSun: Newsletter #89, November 2013

FDA MedWatch Safety Alert

GE Healthcare has initiated a voluntary field corrective for the Avance, Aisys and Avance CS2 anesthesia delivery systems with 8.00 (Avance and Aisys) or 10.00 (Avance CS2) software due to a potential safety issue. To avoid this situation, when using PCV-VG mode, clinicians are advised not to adjust the ventilator tidal volume while in a manual ventilation mode. At any time during the use of the device, should an over delivery of tidal volume occur while in PCV-VG mode, transitioning to a different ventilation mode will resolve the issue.

Additional Information:

Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action. FDA MedWatch Safety Alert. October 15, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371038.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun