Hemodialysis system recalled
The Aquarius Hemodialysis System is being recalled due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm, the FDA announced last week.
The Aquarius Hemodialysis System is being recalled due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm, the FDA announced last week.
The class I 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. A software upgrade will be made to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.