BEUDAMED
    FDA Recall Terminated

    Reliance Synergy Washer/Disinfector

    Recall: Z-1256-2022 · Initiated April 22, 2022

    Recall

    Recall Number
    Z-1256-2022
    Event Number
    90222
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    MEC
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 22, 2022
    Terminated
    November 4, 2024
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    Reliance Synergy Washer/Disinfector

    Reason

    The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.

    Action

    On April 22, 2022, the firm distributed notification letters to affected customers. All affected customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their unit(s) and perform the correction. Users may continue to use their affected devices prior to completion of the correction. Users are reminded to follow instructions outlined in the Operator Manual should the unit alarm "Drying Temperature Too High" by aborting the cycle, positioning building electrical disconnect switch to OFF, and contacting STERIS. If you have questions regarding this issue, please contact Sarah Brown, Senior Product Manager at 440-392-7571, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative.

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    3,863 total units (2,776 US; 1,087 OUS)