Recall Z-0942-2012 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Edwards Lifesciences, Llc
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.
| Date | Feb 2, 2012 (initiated Sep 12, 2008) |
| Status | Terminated |
| Reason | Edwards Lifesciences has made the decision to initiate a field corrective action for the Edwards Vigilance II Model: Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73 due to the potential of inaccurate Injectate Cardiac Output (ICO) measurements. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 6934 instruments |
| Distribution | Worldwide Distribution - Nationwide Distribution (USA) - and the countries of: Argentina, Australia/ New Zealand, Brazil, Canada, China, Columbia, Ecuador, Europe, Indonesia, Japan, Korea, Macao, Malaysia, Mexico, Middle East, Peru, Puerto Rico, Singapore, Thailand, Taiwan and Venezuela |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043103 | VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 Edwards Lifesciences, LLC, Dec 9, 2004 |