BEUDAMED
    FDA Recall Terminated

    NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central control room.

    Recall: Z-2459-2008 · Initiated June 13, 2008

    Recall

    Recall Number
    Z-2459-2008
    Event Number
    49350
    Firm
    Cardinal Health NeuroCare Division
    FEI Number
    3010611950
    Product Code
    GWQ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 13, 2008
    Posted
    September 23, 2008
    Terminated
    December 11, 2011
    Address
    5225 Verona Rd, Madison, WI, 53711-4497

    Description

    NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central control room.

    Reason

    NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. Cardinal Health NeuroCare has confirmed that the 3rd party room relay connected to the A2 wall plate does not always activate if the patient event button connected to the CSeries Amplifier is pressed twice within one second.

    Action

    Consignees were sent a "Cardinal Health Urgent: Medical Device Correction" letter dated June 23, 2008. The letter identified the product and problem. It also provided instructions (Field Correction) to install the software patch and requested return of the verification form. Contact Cardinal Health NeuroCare Division at 1-608-271-3333 for assistance.

    Distribution

    US: AL, AR, CA, CO, FL, GA, IL IN, KY, LA, MO MS, NC, NJ, NY, OH, PA, TN, TX, WA, and WI. OUS: CH, CN, DK, GB, HK, IN, NO, RU, and UK.

    Quantity

    274