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U.S. Department of Health and Human Services

Class 2 Device Recall Vigilance II Monitor

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  Class 2 Device Recall Vigilance II Monitor see related information
Date Initiated by Firm September 12, 2008
Date Posted February 02, 2012
Recall Status1 Terminated 3 on February 08, 2012
Recall Number Z-0942-2012
Recall Event ID 52807
510(K)Number K043103  
Product Classification Computer, diagnostic, pre-programmed, single-function - Product Code DXG
Product 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.
Code Information Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73.  Serial numbers: VG000031 to VG007468
Recalling Firm/
Manufacturer
Edwards Lifesciences, Llc
1 Edwards Way
Irvine CA 92614-5688
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 form to Edwards as record of completion. For questions call Edwards Technical Support department at 800-822-9837.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXG and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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