Recall Z-0380-2007 ยท GWQ Full-Montage Standard Electroencephalograph
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.
| Date | Feb 15, 2007 (initiated Aug 25, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 75 |
| Distribution | Worldwide, including USA, Belgium, Chile, Denmark, Italy, Japan, Poland, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991054 | BRAVO MULTI-MODALITY SYSTEM Nicolet Biomedical, Inc., Nov 3, 1999 |