Edwards Lifesciences Corp. is recalling a hemodialysis system because the system can create a fluid imbalance in patients that may lead to serious injury or death, according to an announcement by the Food and Drug Administration (FDA). Health care professionals have been notified about the recall of Edwards’ Aquarius Hemodialysis System, which is used to clean waste products and excess fluid from a patient’s body after their kidneys have failed. It also monitors the fluid that goes in and out of the patient’s body.

The system has an alarm that sounds when it detects a fluid imbalance in the body. However, the alarm can be overridden, which can disrupt the fluid volume in the body and cause serious injury or death.

The 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. distributes the Aquarius in the United States.

Edwards also notified customers that it plans to upgrade software for the machine to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.

Consumers and healthcare professionals who have experienced adverse events with this or any other product are encouraged to report the event tp the FDA’s MedWatch Adverse Events Reporting Program at www.FDA.gov/MedWatch.