BEUDAMED
    FDA Enforcement Class II Ongoing

    Ventana HE 600 System, automated slide preparer, for use in laboratories.

    Recall: Z-1374-2022 · Reported July 20, 2022

    Enforcement

    Recall Number
    Z-1374-2022
    Event ID
    90363
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ventana Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 20, 2022
    Initiation Date
    June 1, 2022
    Classification Date
    July 12, 2022
    Address
    1910 E Innovation Park Dr, Oro Valley, AZ, 85755-1962, United States

    Description

    Ventana HE 600 System, automated slide preparer, for use in laboratories.

    Reason

    There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire

    Code Info

    All Lots; UDI/DI: 04015630976010

    Distribution

    US: AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD MI MN MO MS MT NC NE NJ NY OH OK OR PA PR SC SD TN TX UT VA WA WI WV OUS: Canada, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, UK, Argentina, Australia, Brazil, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Israel, Japan, Kuwait, Lebanon, Malaysia, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates (UAE), Vietnam

    Quantity

    763 instruments