BEUDAMED
    FDA Recall Terminated

    Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.

    Recall: Z-2345-2012 · Initiated August 24, 2012

    Recall

    Recall Number
    Z-2345-2012
    Event Number
    63102
    Firm
    Volcano Corporation
    FEI Number
    2939520
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 24, 2012
    Posted
    September 10, 2012
    Terminated
    November 25, 2014
    Address
    2870 Kilgore Rd, Rancho Cordova, CA, 95670-6133

    Description

    Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.

    Reason

    The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.

    Action

    Volcano Corporation sent an "IMPORTANT FIELD CORRECTIVE ACTION" letter dated August 24, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact your local Volcano sales representative or Volcano Customer Service for questions regarding this recall.

    Distribution

    Worldwide Distribution.

    Quantity

    1020 units