BEUDAMED
    FDA Enforcement Class II Terminated

    Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220 V. Intended to be used for improving the visibility of objects through magnification and illumination.

    Recall: Z-1726-2014 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1726-2014
    Event ID
    66274
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leica Microsystems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2014
    Initiation Date
    September 11, 2013
    Classification Date
    June 6, 2014
    Termination Date
    April 24, 2017
    Address
    1700 Leider Ln, N/A, Buffalo Grove, IL, 60089-6622, United States

    Description

    Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220 V. Intended to be used for improving the visibility of objects through magnification and illumination.

    Reason

    The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).

    Code Info

    Leica Ceiling Mounts MS-1F, MC-1F; Article Numbers: 10446657, 10446658

    Distribution

    Worldwide Distribution -- USA, including the states of AZ, IL, MA, MO, NC, OR, TX, VA, and WI; and, the countries of Australia, Austria, Chile, China, Colombia, Czech Republic, Greece, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Oman, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, and United Kingdom.

    Quantity

    103 total