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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 3 Recall
NicoletOne monitoring system version 5.20 software		see related information
Date Posted February 15, 2007
Recall Number Z-0380-2007
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
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.
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.
 
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