BEUDAMED
    FDA Recall Terminated

    Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments such as forceps and clamps, theatre shoes and other similar and related articles found in healthcare facilities.

    Recall: Z-3118-2011 · Initiated May 9, 2011

    Recall

    Recall Number
    Z-3118-2011
    Event Number
    59570
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    MEC
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    May 9, 2011
    Posted
    September 1, 2011
    Terminated
    March 1, 2013
    Address
    5960 Heisley Rd, Mentor, OH, 44060

    Description

    Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments such as forceps and clamps, theatre shoes and other similar and related articles found in healthcare facilities.

    Reason

    STERIS learned that Vision SC Washer users were experiencing nuisance alarms and/or aborted cycles that are adversely affecting the reliability and operation of their unit.

    Action

    The firm, STERIS sent an "URGENT FIELD CORRECTION NOTICE" letter dated May 9, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed that they can continue using their Vision SC Washer(s) prior to installation of the system upgrades. The letter states that STERIS is correcting the issues by implementing a series of quality improvements to the customers Vision SC Washer(s) to ensure satisfaction. Additionally, a STERIS Service Representative will contact the customers facility to arrange for STERIS to upgrade their Vision SC Washer(s). For further information or if you have questions regarding the servicing of your unit, please contact STERIS Field Service Dispatch at 1-800-333-8828.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: L, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI and WY; and countries of: Australia, Canada, Hong Kong and South Korea.

    Quantity

    404 Units