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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 Device Recall NicoletOne monitoring system version 5.20 software see related information
Date Initiated by Firm August 25, 2006
Date Posted February 15, 2007
Recall Status1 Terminated 3 on December 10, 2011
Recall Number Z-0380-2007
Recall Event ID 36241
510(K)Number K991054  
Product Classification patient monitoring system - 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 WI 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		 Other
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 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 = GWQ and Original Applicant = NICOLET BIOMEDICAL, INC.
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