Recall of the Vigilance monitors from Edwards Lifesciences Services
2006.07.17
Product group Medical electronics / Electromedical devices
Reference 01979/06
Edwards Lifesciences Services GmbH has issued an information concerning a recall of the Vigilance (formerly Baxter Vigilance) monitors distributed prior to March 2003 with software release 5.3E or earlier. There is a risk that the monitor delivers power to the Continuous Cardiac Output (CCO) catheter without alerting. This can result in overheating and thermal damage to the CCO catheter and serious patient injury.
Recall of the Vigilance monitors from Edwards Lifesciences Services , Download_VeroeffentlichtAm_EN