BEUDAMED
    FDA Recall Open, Classified

    Nussloch GmbH ASP6025 Tissue Processor

    Recall: Z-2660-2017 · Initiated June 19, 2017

    Recall

    Recall Number
    Z-2660-2017
    Event Number
    77603
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    IEO
    Status
    Open, Classified
    Root Cause
    Labeling mix-ups
    Initiated
    June 19, 2017
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622

    Description

    Nussloch GmbH ASP6025 Tissue Processor

    Reason

    Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit.

    Action

    Customers were notified via email on 06/19/2017. Instructions to customers included to clean surface around the Alarm Connectors and place the newly provided label at the Alarm Connectors (over the engraved specification). They were also instructed to update their current Instructions For Use and update the online help function in the software, as well as return the response form.

    Distribution

    Domestic: AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV, & DC. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, England, France, Georgia, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lithuania, Malaysia, Maldives, Mexico, Morocco, Myanmar, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, & United Arab Emirates.

    Quantity

    812 units