Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73. Product Usage: The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular, ejection, fraction, and end diastolic volume.

Edwards initiated two Urgent Product Notification - Action Required letters to all affected customers. The letters identified the affected product, problem, and actions to be taken. The letters instructed users to immediately discontinue use of in-line temperature probes for Intermittent Cardiac Output (ICO) measurements on the Vigilance II instrument and recommends use of the bath probe only (model 9850A) to measure the temperature of the injectate solution for ICO calculations, until software update have been completed. Customers were instructed to complete and return a software upgrade form to Edwards as record of completion. For questions call Edwards Technical Support department at 800-822-9837.