BEUDAMED
    FDA Recall Terminated

    VersaRad/Traumex General Radiographic System.

    Recall: Z-0974-04 · Initiated April 23, 2004

    Recall

    Recall Number
    Z-0974-04
    Event Number
    28995
    Firm
    Fischer Imaging Corporation
    FEI Number
    1418957
    Product Code
    IYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 23, 2004
    Posted
    July 20, 2004
    Terminated
    March 13, 2012
    Address
    12300 Grant St, Denver, CO, 80241-3120

    Description

    VersaRad/Traumex General Radiographic System.

    Reason

    If two of the four T-nuts that connect the transverse rail to the ceiling rail fail, the 'U' arm and transverse rails could fall and cause serious injury.

    Action

    Consignees were notified by letter on 4/23/2004.

    Distribution

    Nationwide, including VA facilities in MI, MN and VT. No military consignees. Foreign distribution to Australia, Canada, Denmark, Italy, Korea, Netherlands, Norway, Sweden, United Kingdom.

    Quantity

    138 units