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.
FDA Recall Z-0380-2007 · Posted 2007-02-15
Recalling FirmNicolet Biomedical Div of Viasys Healthcare
Recall StatusTerminated
Product CodeGWQ
Date Initiated2006-08-25
Date Terminated2011-12-10
Product Quantity75
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Belgium, Chile, Denmark, Italy, Japan, Poland, and Spain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.