BEUDAMED
    FDA Enforcement Class II Completed

    Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in

    Recall: Z-2262-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2262-2020
    Event ID
    85526
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Ventana Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2020
    Initiation Date
    October 4, 2019
    Classification Date
    June 5, 2020
    Address
    1910 E Innovation Park Dr, N/A, Oro Valley, AZ, 85755-1962, United States

    Description

    Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in

    Reason

    The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components.

    Code Info

    All lots

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MD, MI, MA, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, Croatia, Denmark, Ecuador, El Salvador, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Kuwait, Lebanon, Malaysia, Norway, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam.

    Quantity

    461