BEUDAMED
    FDA Recall Terminated

    Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden.

    Recall: Z-0504-2007 · Initiated November 9, 2006

    Recall

    Recall Number
    Z-0504-2007
    Event Number
    36855
    Firm
    Stille-Sonesta, Inc
    FEI Number
    1000516389
    Product Code
    IXR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 9, 2006
    Posted
    February 15, 2007
    Terminated
    June 20, 2007
    Address
    2220 Canton St, Apt 209, Dallas, TX, 75201-5932

    Description

    Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden.

    Reason

    Bolts may back out of their joints causing the back section of the table to tilt.

    Action

    Notifications letters sent to consignees on 11/20/06. Users are instructed to check the bolts located under the table. The Notice includes instructions with pictures for checking the bolts and tightening them if necessary. Stille AB has developed a kit for replacing the bolt that is involved and will send a service engineer out to the site to do the replacement.

    Distribution

    Nationwide.

    Quantity

    66 units.