BEUDAMED
    FDA Recall Open, Classified

    Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062

    Recall: Z-1595-2023 · Initiated April 10, 2023

    Recall

    Recall Number
    Z-1595-2023
    Event Number
    92044
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    MEC
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 10, 2023
    Posted
    May 17, 2023
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062

    Reason

    In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.

    Action

    An URGENT MEDICAL DEVICE FIELD CORRECTION dated 3/28/23 was sent to customers. STERIS Action: All affected Customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their unit(s) to perform the correction. User Action: Users can continue to use their Reliance Vision Multi-Chamber Washer/Disinfector prior to completion of the correction. Should your unit alarm Drying Temperature Too High, abort the cycle, turn off the power to the unit, and contact STERIS. The competent (regulatory) authority of your country has been informed of this notice. Customer response is not required. Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact 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) and OUS (Foreign) to countries of: China, Lithuania, Saudi Arabia, Korea, Republic of, Canada, Taiwan, United Kingdom, Spain, Australia, New Zealand, Spain, Brazil, Bahrain, Switzerland, Great Britain, South Africa, Hong Kong, Qatar.

    Quantity

    322 units