GE Healthcare Aisys and Avance Anesthesia Systems: Recall

GE Healthcare Aisys and Avance Anesthesia Systems: Recall
Audience: Anesthesiology healthcare professionals
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.
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: www.fda.gov/MedWatch/report.htm
Phone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch Download Forms page, to address on the pre-addressed form
Fax: 1-800-FDA-0178
Read the complete MedWatch 2010 Safety summary, including a link to the Recall Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211918.htm

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GE Healthcare Aisys and Avance Anesthesia Systems: Recall