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U.S. Department of Health and Human Services

Class 3 Device Recall NicoletOne monitoring system version 5.20 software

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 Class 3 Recall
NicoletOne monitoring system version 5.20 software
see related information
Date Posted February 15, 2007
Recall Status1 Open
Recall Number Z-0380-2007
Recall Event ID 36241
Premarket Notification
510(K) Number
K991054 
Product Classification Full-Montage Standard Electroencephalograph - Product Code GWQ
Product NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems.
Code Information NicoletOne Version 5.20 software released and installed after August 07, 2006.
Recalling Firm/
Manufacturer
Nicolet Biomedical Div of Viasys Healthcare
5225 Verona Rd
Madison, Wisconsin 53711-4497
Manufacturer Reason
for Recall
A software anomaly exists in the 5.20.1038 NicoletOne LTM, Sleep, nEEG, vEEG and ICU Monitor systems using the M, and/or C series amplifiers. If this anomaly occurs, the system will display the data for channel one in all channels on NicoletOne LTM, Sleep, nEEG, vEEG or ICU Monitor systems.
FDA Determined
Cause 2
DESIGN: Software Design
Action An Advisory Notice, dated August 25, 2006, was sent to all affected customers. The notice described the issues, states to discontinue use of 5.20.1038 software until updated 5.21.1039c software is installed.
Quantity in Commerce 75
Distribution Worldwide, including USA, Belgium, Chile, Denmark, Italy, Japan, Poland, and Spain.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GWQ and Original Applicant = NICOLET BIOMEDICAL, INC.
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