Recall announced for GE Aisys and Avance anesthesia systems
GE Healthcare and the Food and Drug Administration (FDA) notified healthcare professionals of a Class I recall of certain lots of the Aisys and Avance Anesthesia Systems. The control board wiring harnesses have a defect which can cause the machines to unexpectedly shut down, terminating ventilation, anesthetic delivery and potentially patient monitoring.
Healthcare professionals are encouraged to report adverse events related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online, or by phone at 1-800-332-1088. Healthcare professionals can also report via mail using the postage-paid FDA form 3500, which can be downloaded from the MedWatch Download Forms page, to the address on the pre-addressed form; or by fax, at 1-800-FDA-0178.
Click here for the complete MedWatch 2010 Safety summary, including a link to the Recall Notice.
Healthcare professionals are encouraged to report adverse events related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online, or by phone at 1-800-332-1088. Healthcare professionals can also report via mail using the postage-paid FDA form 3500, which can be downloaded from the MedWatch Download Forms page, to the address on the pre-addressed form; or by fax, at 1-800-FDA-0178.
Click here for the complete MedWatch 2010 Safety summary, including a link to the Recall Notice.