BEUDAMED
    FDA Enforcement Class III Terminated

    VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.

    Recall: Z-1832-2014 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1832-2014
    Event ID
    68320
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2014
    Initiation Date
    April 25, 2014
    Classification Date
    June 19, 2014
    Termination Date
    April 16, 2015
    Address
    62 Flanders-Bartley Rd, N/A, Flanders, NJ, 07836-4715, United States

    Description

    VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.

    Reason

    The keyboard and monitor may not be properly secured to the monitor arm.

    Code Info

    Siemens Material Numbers: Instrument 10793839, Expansion Pack 10913528

    Distribution

    Worldwide Distribution - USA including Iowa and New York and Internationally to Canada, Chile, France, India, Italy, Malaysia, Peru, Korea, and the United Kingdom.

    Quantity

    19 units