BEUDAMED
    FDA Recall Terminated

    Cmax Surgical Tables, Model #'s: Cmax110, Cmax 220 manufactured by Steris Corporation in Montgomery, AL

    Recall: Z-0624-2011 · Initiated August 12, 2010

    Recall

    Recall Number
    Z-0624-2011
    Event Number
    56659
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 12, 2010
    Posted
    December 16, 2010
    Terminated
    September 27, 2012
    Address
    5960 Heisley Rd, Mentor, OH, 44060

    Description

    Cmax Surgical Tables, Model #'s: Cmax110, Cmax 220 manufactured by Steris Corporation in Montgomery, AL

    Reason

    Cmax Surgical Tables may lose calibration if the table is operated only on battery power and if the table is in a low battery charge condition. This could result in the table moving into an unexpected tilt position when the Level button is depressed on the hand control keypad.

    Action

    Steris issued Urgent Field Correction Notice letters dated August 26, 2010 to each affected consignee notifying them of the voluntary field correction. A Steris Representative will contact customers to arrange for STERIS to upgrade the software in the table. For further information about this corrective action, contact Steris at 1 800 333-8828.

    Distribution

    Worldwide Distribution: USA in the following states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV, and in the countries of Australia, Canada, China, Columbia, Dominican Republic, India, Israel, Mexico, New Zealand, Saudi Arabia, Singapore, South Korea and Taiwan.

    Quantity

    1,635 tables