BEUDAMED
    FDA Recall Terminated

    Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA.

    Recall: Z-0168-2011 · Initiated June 29, 2010

    Recall

    Recall Number
    Z-0168-2011
    Event Number
    56794
    Firm
    Volcano Corporation
    FEI Number
    2939520
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 29, 2010
    Posted
    November 1, 2010
    Terminated
    December 22, 2010
    Address
    2870 Kilgore Rd, Rancho Cordova, CA, 95670-6133

    Description

    Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA.

    Reason

    Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification of tissue types. This may result in misdiagnosis and inappropriate treatment.

    Action

    Volcano issued a Voluntary Recall of Volcano s5 Family Software version 3.2 letter dated June 30, 2010, identifying the software defect and actions to be taken by Volcano. Field Service Engineers will visit each site and reinstall the previous software version, which will resolve the issue. Customers can contact Volcano at 916 281-2790.

    Distribution

    Worldwide Distribution: USA, and the countries of France, Germany, Japan, and the UK.

    Quantity

    79 software kits