Class I Recall for GE Healthcare’s Aisys and Avance Anesthesia Systems

GE Healthcare is recalling <"">Aisys and Avance Anesthesia Systems. The U.S. Food & Drug Administration (FDA) has deemed this a Class I recall, its most serious recall action. A Class I recall involves situations in which there is a reasonable probability that use of a device will cause serious adverse health consequences or death.

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.

According to the recall notice, 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.

This recall affects Anesthesia Systems distributed between October 9, 2009 and October 29, 2009. Devices included in this recall are:

Aisys Anesthesia Systems, Model No. 1011-9000-000 with Lot/Serial Numbers: ANAN00814, ANAN00815, ANAN00825, ANAN00830, ANAN00831, ANAN00831, ANAN00832, ANAN00833, ANAN00834, ANAN00835, ANAN00836, ANAN00837, ANAN00838, ANAN00839, ANAN00873

Avance Anesthesia Systems, Model No. 1009-9002-000 with Lot/Serial Numbers: ANBN01180, ANBN01187, ANBN01200, ANBN01201, ANBN01211, ANBN01212, ANBN01213, ANBN01220, ANBN01223, ANBN01224, ANBN01250, ANBN01266, ANBN01284, ANBN01285, ANBN01286, ANBN01287, ANBN01288, ANBN01289

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.

Questions about this recall can be directed to E Healthcare Customer Service, available 8:30am – 5:00 pm, Monday through Friday, at 1-800-654-0118 or at (262) 544-3894.

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.

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