BEUDAMED
    FDA Recall Terminated

    Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM)

    Recall: Z-1190-2007 · Initiated April 2, 2007

    Recall

    Recall Number
    Z-1190-2007
    Event Number
    38324
    Firm
    Volcano Corporation
    FEI Number
    2939520
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 2, 2007
    Posted
    August 23, 2007
    Terminated
    June 3, 2008
    Address
    2870 Kilgore Rd, Rancho Cordova, CA, 95670-6133

    Description

    Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM)

    Reason

    During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.

    Action

    The firm notified its customers by letter beginning April 2, 2007, and started replacing the monitor with appropriate replacement parts.

    Distribution

    Product was distributed to health care facilities nationwide and to distributors in Europe (via subsidiary), Japan (via subsidiary), Latin America and Asia (third party distributors).

    Quantity

    351 units worldwide