BEUDAMED
    FDA Recall Terminated

    The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.

    Recall: Z-2026-2014 · Initiated June 27, 2014

    Recall

    Recall Number
    Z-2026-2014
    Event Number
    68678
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 27, 2014
    Posted
    July 9, 2014
    Terminated
    September 16, 2015
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.

    Reason

    STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. If one or more of the table floor lock feet become unlocked due to the loss of hydraulic pressure, there is a potential for the table hand control to incorrectly indicate that the floor lock feet are locked.

    Action

    STERIS sent an Urgent Voluntary Field Correction Noticel letter dated June 27, 2014 to affected Customers.via FedEx with tracking numbers for delivery confirmation. The letter identified the description of the product, description of the problem and the actions to be taken. For questions contact Steris Field Service Dispatch at 1-800-333-8828.

    Distribution

    Worldwide Distribution - US (nationwide in the states of AL, AK, AZ, AR, CA,CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY in the countries of Canada, India, Vietnam, China, India, Korea, Mexico, costa Rica, Brazil, Taiwan, Australia, New Zealand, El Salvador, Indonesia, Hong Kong, Singapore, Nepal.

    Quantity

    3689