BEUDAMED
    FDA Recall Terminated

    Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Ventana Medical Systems, Tucson, AZ

    Recall: Z-0300-2008 · Initiated September 6, 2007

    Recall

    Recall Number
    Z-0300-2008
    Event Number
    45437
    Firm
    Ventana Medical Systems Inc
    FEI Number
    1000125183
    Product Code
    KEY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 6, 2007
    Posted
    January 9, 2008
    Terminated
    July 8, 2008
    Address
    1910 E Innovation Park Dr, Tucson, AZ, 85755-1962

    Description

    Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Ventana Medical Systems, Tucson, AZ

    Reason

    Shock hazard: Devices released prior to full testing; the configuration of the Symphony instrument during Hi pot testing procedures did not completely evaluate all components in the test loop. In specific circumstances, a shock hazard exists.

    Action

    On 9/6/07, the firm began visiting customers to perform the HiPot test. Prior to performing the High Potential Test of Symphony Instruments already in the Field, the Field Service Engineer or FSE ensures that the customer fully understands the purpose of the test and why it is necessary to perform the test at their site. The FSE conveys the following points regarding the HiPot test: - The HiPot test is a safety verification for the electrical path within the instrument. - The HiPot test was performed incorrectly during the manufacturing process. - The HiPot test is used to verify that if a high voltage overload condition were to occur it would not lead to a short/arc within the instrument, which could pose a risk to anyone that touches the instrument - The HiPot test places a voltage of 2,000VDC onto the high voltage path of the instrument and if any of the insulating components are compromised, the tester will notify the FSE of the condition. - If the instrument fails the HiPot test, the faulty component will be replaced and the instrument will be retested until it passes. - Due to the high voltage used the during the test, no one will be allowed to touch the instrument until the test is complete. The FSE performing the test documents that the customer was informed of the reason for the High Potential Test on their Field Service Report.

    Distribution

    Worldwide: USA, Japan and France

    Quantity

    45 units