BEUDAMED
    FDA Recall 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 · Initiated September 11, 2013

    Recall

    Recall Number
    Z-1726-2014
    Event Number
    66274
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    OUE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 11, 2013
    Posted
    June 7, 2014
    Terminated
    April 24, 2017
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622

    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).

    Action

    A Medical Device Correction letter, dated September 11, 2013, was sent to all direct accounts. The letters advised customers that a Leica Microsystems representative will contact them and make arrangements to conduct an inspection of the ceiling mount(s) and to provide additional preventative maintenance and inspection protocols for the devices. Customers are asked to complete and return the enclosed Acknowledgement Form and send it back to Leica Microsystems within 10 days of receiving the Medical Device Correction letter. Customers with questions should contact their Leica Microsystems representative.

    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