FDAnews Device Daily Bulletin

MHRA Issues Medical Device Alert for Gas Outlet

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The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert for GE Healthcare’s Auxiliary Common Gas Outlet (ACGO). An incorrect setting of the ACGO switch will result in no fresh gas flow to the patient. Furthermore, if the circle breathing circuit is incorrectly attached to the ACGO, this may result in barotrauma.