Class I Medical Device Recall: GE Healthcare Aisys and Avance Anesthesia Systems
Company, Product(s): GE Healthcare Aisys and Avance Anesthesia Systems
Recall Class: Class I
Date Recall Initiated: May 10, 2010
Product Names: The affected Anesthesia Systems were distributed between October 9, 2009 and October 29, 2009.
|Model Name||Model Number||Lot/Serial Numbers|
|Aisys||1011-9000-000||ANAN00814, ANAN00815, ANAN00825, ANAN00830, ANAN00831, ANAN00831, ANAN00832, ANAN00833, ANAN00834, ANAN00835, ANAN00836, ANAN00837, ANAN00838, ANAN00839, ANAN00873|
|Avance||1009-9002-000||ANBN01180, ANBN01187, ANBN01200, ANBN01201, ANBN01211, ANBN01212, ANBN01213, ANBN01220, ANBN01223, ANBN01224, ANBN01250, ANBN01266, ANBN01284, ANBN01285, ANBN01286, ANBN01287, ANBN01288, ANBN01289|
Use: The Aisys and Avance Anesthesia Systems are prescription devices used in healthcare settings under the supervision of a physician. They are intended to provide general inhalation anesthesia and ventilation support to a wide range of patients. These devices are intended for volume or pressure control ventilation.
GE Healthcare, LLC
3000 N Grandview Blvd.
Waukesha, Wisconsin 53188-1615
Reason for Recall: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harnesses have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
Public Contact: If you need assistance or have questions about this recall or your GE Healthcare Aisys or Avance Anesthesia Systems, call GE Healthcare Customer Service, available 8:30am Ã¢?" 5:00 pm, Monday through Friday, at 1-800-654-0118 or at (262) 544-3894.
FDA District: Minneapolis
FDA Comments: Customers were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
Any adverse events experienced with the use of this product or quality problems may be reported to the FDA's MedWatch Program by phone at 1-800-FDA-l088.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.