BEUDAMED
    FDA Recall Terminated

    VersaRad Generator

    Recall: Z-0787-05 · Initiated September 30, 2004

    Recall

    Recall Number
    Z-0787-05
    Event Number
    31443
    Firm
    Fischer Imaging Corporation
    FEI Number
    1418957
    Product Code
    IYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 30, 2004
    Posted
    May 3, 2005
    Terminated
    March 13, 2012
    Address
    12300 Grant St, Denver, CO, 80241-3120

    Description

    VersaRad Generator

    Reason

    Some VersaRad Systems have a faulty weld that may result in oil leakage.

    Action

    Customers were sent notification letters.

    Distribution

    Domestic distribution: ... International distribution: Germany, Greece, Italy, Kuwait, Spain, Sweden, Switzerland. No VA or military facilities.

    Quantity

    38 units