GE receives class I warning for anaesthesia systems recall
This article was originally published in Clinica
Executive Summary
GE Healthcare’s recall of its Aisys and Avance anaesthesia systems has been given a class I notice from the US FDA. GE initiated the recall on 10 May 2010 after it discovered that the devices’ control board wiring harnesses had a defect, which could cause them to unexpectedly shut down or terminate ventilation, aesthetic delivery and, potentially, patient monitoring. The affected systems were distributed 9-29 October 2009. The Aisys and Avance systems are prescription devices used in healthcare settings under the supervision of a physician for providing general inhalation anaesthesia and ventilation support.
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