BEUDAMED
    FDA Enforcement Class II 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 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-2026-2014
    Event ID
    68678
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 16, 2014
    Initiation Date
    June 27, 2014
    Classification Date
    July 9, 2014
    Termination Date
    September 16, 2015
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834, United States

    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.

    Code Info

    All Model Numbers

    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