Company: Edwards Lifesciences Llc,
Date of Enforcement Report:8/23/2006
Edwards Vigilance Monitors (Formerly Baxter Vigilance Monitors). Patient monitor which measures cardiac output. Models: VG, VGS, VGS1, VGS2, VG2, & IVM, Recall # Z-1310-06
Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter without alerting the user to this situation. This can result in overheating and thermal damage to the CCO catheter and serious patient injury.
All devices serialized with software release 5.3 or earlier.
Edwards Lifesciences Llc, Irvine, CA, by telephone and letter dated July 7, 2006. Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally