An anesthetic system used to provide general inhalation anesthesia and ventilation support is being recalled by the manufacturer because the devices may have a defect that can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring. This recall falls under the FDA’s Class 1 classification, which is the most serious type of recall issued by the agency and is reserved for products in which there is a reasonable probability that use of the products will cause serious adverse health consequences or death.
The recall includes specific lots of the Aisys and Avance Anesthesia Systems manufactured by GE Healthcare. The systems may have a defect in the control board wiring harness that can cause it to malfunction. The devices are prescribed by physicians to provide general inhalation anesthesia and volume or pressure control ventilation to a wide range of patients in healthcare settings.
The recall notice affects anesthesia systems distributed between October 9, 2009, and October 29, 2009. Customers received a GE Healthcare “Urgent Medical Device Correction” letter dated March 12, 2010. The recall includes specific lot and serial numbers of Aisys model number 1011-9000-000 and Avance model number 1009-9002-000.
Any adverse events associated with this or any other device should be reported to the FDA MedWatch Adverse Events Reporting program at www.FDA.gov/MedWatch.