The Food and Drug Administration (FDA) and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in volume fluctuation of circulating blood, which could cause serious injuries or death.
The medical device recall includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. Baxter International, Inc. is the U.S. distributor of the Aquarius.
The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.