FDA and GE Issue Class I Recall of Anesthesia Systems

Specific lots of Aisys, Avance systems have defect that may result in unexpected shutdowns
By Beth Gilbert
HealthDay Reporter

THURSDAY, May 13 (HealthDay News) -- The U.S. Food and Drug Administration and GE Healthcare have alerted health care professionals of a Class I recall of specific lots of Aisys and Avance Anesthesia Systems due to a defect in the control board wiring harnesses.

The Aisys and Avance Anesthesia Systems are used in a wide range of patients to provide general inhalation anesthesia and ventilation support. They are intended for volume or pressure control ventilation.

The recall was issued because the defect may cause the devices to unexpectedly turn off, which would terminate ventilation and anesthetic delivery and possibly patient monitoring. The affected systems were distributed between October 9 and October 29, 2009.

"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 8:30 a.m. to 5:00 p.m., Monday through Friday, at 1-800-654-0118," the FDA said in a news release.

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