BEUDAMED
    FDA Recall Terminated

    ValueLine Mat Platform Model C2230A,B,C; C922-30A, B,and C; C6904, C6903, C6902, C6901. All tables have the standard platform and the model numbers represent the additional shelves or drawers and the arrangement.

    Recall: Z-1207-06 · Initiated January 25, 2006

    Recall

    Recall Number
    Z-1207-06
    Event Number
    34510
    Firm
    SAMMONS PRESTON ROLYAN
    FEI Number
    2128677
    Product Code
    INT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 25, 2006
    Posted
    July 12, 2006
    Terminated
    April 1, 2007
    Address
    W.68 N.158 Evergreen Blvd., Cedarburg, WI, 53012

    Description

    ValueLine Mat Platform Model C2230A,B,C; C922-30A, B,and C; C6904, C6903, C6902, C6901. All tables have the standard platform and the model numbers represent the additional shelves or drawers and the arrangement.

    Reason

    There have been reports of structural failure on the skirt of select tables. The risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced.

    Action

    Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.

    Distribution

    Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV.

    Quantity

    561 devices total