August 4, 2008 - Levitronix and FDA are notifying healthcare professionals of a class 1 recall of the Levitronix CentriMag Extracorporeal Blood Pumping System and Primary and Backup Consoles manufactured by Levitronix, GmbH, Zurich, Switzerland.
A July 24, 2008 Levitronix device correction letter informed physicians not to use Valleylab Force FX-C or SSE2L electrosurgery devices with the CentriMag Blood Pumping System because use may result in stoppage of the pump and may cause serious injury or death. This recall action is an interim fix while the firm further investigates the source of the problem.
The machines being recalled were distributed from January 2001 through March 2008. The blood pumping system is used to provide short-term extracorporeal circulatory support during cardiac and other types of surgeries. This device temporarily replaces the function of the heart and lungs in order to maintain the appropriate circulation of blood and oxygen levels in the body during the surgical procedure.
For more information: www.fda.gov/medwatch/safety/2008/safety08.htm#CentriMag