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.
This recall has been terminated (originally issued February 15, 2007).
- Recall Initiated
- August 25, 2006
- Posted
- February 15, 2007
- Terminated
- December 10, 2011
- Recall Number
- Z-0380-2007
- Quantity
- 75
- Firm Location
- Madison, WI
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide, including USA, Belgium, Chile, Denmark, Italy, Japan, Poland, and Spain.
Lot / Code Info
NicoletOne Version 5.20 software released and installed after August 07, 2006.
Root Cause
Other
Action Taken
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.