BEUDAMED
    FDA Recall Terminated

    AADCO Rayshield Frame Mounted Overhead X-Ray Barrier; Models: E3051AR S-568, 60 x 80 cm Frame Mounted Barrier with Cut-out, E3051AS S-568HL, 60 x 80 cm Frame Mounted Barrier with Cut-out and lamp, E3051AT S-634, 30 x 40 cm Frame Mounted Barrier, E3051AW S-645S, 40 x 50 cm Frame Mounted Barrier, E3051AY S-634HL, 30 x 40 cm Frame Mounted Barrier with lamp, and E3051AZ S-645SHL, 40 x 50 cm Frame Mounted Barrier with lamp, AADCO Medical, Inc., Randolph, VT. 05060

    Recall: Z-0552-2008 · Initiated November 1, 2007

    Recall

    Recall Number
    Z-0552-2008
    Event Number
    45888
    Firm
    Aadco Medical Inc.
    FEI Number
    3001237319
    Product Code
    IWX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 1, 2007
    Posted
    January 25, 2008
    Terminated
    May 2, 2012
    Address
    2279 Vermont Rte. 66, Randolph, VT, 05060

    Description

    AADCO Rayshield Frame Mounted Overhead X-Ray Barrier; Models: E3051AR S-568, 60 x 80 cm Frame Mounted Barrier with Cut-out, E3051AS S-568HL, 60 x 80 cm Frame Mounted Barrier with Cut-out and lamp, E3051AT S-634, 30 x 40 cm Frame Mounted Barrier, E3051AW S-645S, 40 x 50 cm Frame Mounted Barrier, E3051AY S-634HL, 30 x 40 cm Frame Mounted Barrier with lamp, and E3051AZ S-645SHL, 40 x 50 cm Frame Mounted Barrier with lamp, AADCO Medical, Inc., Randolph, VT. 05060

    Reason

    Screws may become loose from the mounted shield compromising stability

    Action

    AADCO Medical Inc., issued a Product Safety Notification/recall letter to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists and Cardiologists dated 11/1/07. AADCO will perform on site inspections with device tightening or replacement of parts as needed; at no cost the the users

    Distribution

    Worldwide; USA, Canada, Mexico, Brazil, Venezula, Chile, Bermuda, Spain, and Panama

    Quantity

    324 units