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Class I Medical Device Recall: GE Healthcare Aisys and Avance Anesthesia Systems

Thu, 05/13/2010 - 7:42am
U.S. Food & Drug Administration

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.

Recalling Firm:

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 â?" 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.

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