BEUDAMED
    FDA Recall Terminated

    NicoletOne photic adapter cable 085-463700

    Recall: Z-2389-2008 · Initiated June 5, 2008

    Recall

    Recall Number
    Z-2389-2008
    Event Number
    48758
    Firm
    Cardinal Health NeuroCare Division
    FEI Number
    3010611950
    Product Code
    GWQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 5, 2008
    Posted
    September 21, 2008
    Terminated
    October 13, 2010
    Address
    5225 Verona Rd, Madison, WI, 53711-4497

    Description

    NicoletOne photic adapter cable 085-463700

    Reason

    Cardinal Health NeuroCare is implementing a voluntary field correction to replace a quantity of photic adapter cables, part number 085-463700, used to connect the NicLED Photic Strobe option, part number 698-625500, with NicoletOne EEG system. The photic adapter cable has a wiring error which delivers a reduced voltage and results in a decreased intensity of the NicLED photic. This reduced intensi

    Action

    A "Cardinal Health Urgent: Medical Device Correction" letter was sent to consignees. The letter described the product and the problem. The consignees were asked to confirm completion of the cable exchange by returning an information card. If you have questions, contact Cardinal Health (formerly VIASYS) NeuroCare Technical Support Group at 1-800-356-0007 (US), 608-273-5000 (OUS) or email [email protected].

    Distribution

    CA FL GA ID IN LA MD ME MI MO NC NY PA TN TX WA WI China Denmark Indonesia Japan Korea Mexico Netherlands Russia Saudi Arabia Slovenia

    Quantity

    92