BEUDAMED
    FDA Recall Terminated

    ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide complete and flexible positioning for surgical procedures.

    Recall: Z-1597-2009 · Initiated April 17, 2009

    Recall

    Recall Number
    Z-1597-2009
    Event Number
    51953
    Firm
    Steris Corp
    FEI Number
    1527821
    Product Code
    GDC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 17, 2009
    Posted
    July 7, 2009
    Terminated
    March 1, 2012
    Address
    5960 Heisley Rd, Mentor, OH, 44060

    Description

    ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide complete and flexible positioning for surgical procedures.

    Reason

    Upon investigation, the firm determined that repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hoses causing loss of control of the table surface.

    Action

    A Field Correction Notice dated April 17, 2009 was issued to customers. The letter described the potential problem of the unit. The letter also notified customers of the corrective actions to be taken by the firm. A Steris technician will visit affected accounts to inspect the hydraulic hoses and replace any that show abrasion and will make other preventive corrections. For further information or if you have questions regarding the servicing of your unit, please contact the STERIS Field Service Dispatch at 1-800-288-2805.

    Distribution

    Worldwide Distribution -- US (states of AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, VA and WV), AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, ECUADOR, GERMANY, HONG KONG, INDIA, INDONESIA, ITALY, KOREA, MEXICO, PHILIPPINES, PORTUGAL, SINGAPORE, SPAIN, SRI LANKA and THAILAND.

    Quantity

    412 units