BEUDAMED
    FDA Recall Terminated

    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: Z-0380-2007 · Initiated August 25, 2006

    Recall

    Recall Number
    Z-0380-2007
    Event Number
    36241
    Firm
    Nicolet Biomedical Div of Viasys Healthcare
    FEI Number
    3010611950
    Product Code
    GWQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 25, 2006
    Posted
    February 15, 2007
    Terminated
    December 10, 2011
    Address
    5225 Verona Rd, Madison, WI, 53711-4497

    Description

    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.

    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.

    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.

    Distribution

    Worldwide, including USA, Belgium, Chile, Denmark, Italy, Japan, Poland, and Spain.

    Quantity

    75