Nicolet Biomedical Div of Viasys Healthcare 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Nicolet Biomedical Div of Viasys Healthcare
Lot Codes / Batch Numbers
NicoletOne Version 5.20 software released and installed after August 07, 2006.
Products Sold
NicoletOne Version 5.20 software released and installed after August 07, 2006.
Nicolet Biomedical Div of Viasys Healthcare is recalling NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the Nicol due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026