BEUDAMED
    FDA Enforcement Class II Terminated

    Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.

    Recall: Z-2177-2013 · Reported September 18, 2013

    Enforcement

    Recall Number
    Z-2177-2013
    Event ID
    64601
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leica Microsystems (Schweiz) Ag
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    September 18, 2013
    Initiation Date
    December 18, 2012
    Classification Date
    September 10, 2013
    Termination Date
    April 24, 2017
    Address
    201 Max Schmidheiny-Strasse, N/A, Heerbrugg, N/A, N/A, Switzerland

    Description

    Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.

    Reason

    The brake in the Z axis and/or brakes in the AB and C axes failed during installation.

    Code Info

    Serial Numbers: OH5-45912, OH5-46012, OH5-46112, OH5-46212, OH5-46312, OH5-46412, OH5-46512, OH5-46612, OH5-46712, OH5-46912, OH5-47012, OH5-47112, OH5-47212, OH5-47312, OH5-47412, OH5-47512, OH5-47612, OH5-47812, OH5-47912, OH5-48012, OH5-48112, OH5-48212, OH5-48312, OH5-48312

    Distribution

    Worldwide distribution: USA (Nationwide) including states of: AK, CA, CO, NY, and OR; and countries of: Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.

    Quantity

    28 units