BEUDAMED
    FDA Recall Terminated

    Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Model Number: 2147-671) VIASYS NeuroCare Part Numbers: 842-673800, 842-673900, 982A0421 and 982A0422. Manufactured, designed, developed and marketed by VIASYS NeuroCare Inc., Madison, WI 53711

    Recall: Z-0126-2008 · Initiated September 11, 2007

    Recall

    Recall Number
    Z-0126-2008
    Event Number
    45328
    Firm
    Nicolet Biomedical Div of Viasys Healthcare
    FEI Number
    3010611950
    Product Code
    GWQ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 11, 2007
    Posted
    January 3, 2008
    Terminated
    December 10, 2011
    Address
    5225 Verona Rd, Madison, WI, 53711-4497

    Description

    Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Model Number: 2147-671) VIASYS NeuroCare Part Numbers: 842-673800, 842-673900, 982A0421 and 982A0422. Manufactured, designed, developed and marketed by VIASYS NeuroCare Inc., Madison, WI 53711

    Reason

    Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option.

    Action

    Certified direct mail delivery of URGENT MEDICAL DEVICE FIELD CORRECTION (RECALL) were made to consignees on 9/11/07 by Nicolet Biomedical Div of Viasys Healthcare. The letter describes the product and problem. VIASYS requests that customers cease use of the video option of the device until the monitor can be replaced by VIASYS authorized personnel. Letter also requests consignees to fax or mail back the response form.

    Distribution

    Worldwide Dsitribution - USA, Germany, Netherlands, Kuwait, Japan, Ireland, and China.

    Quantity

    33