BEUDAMED
    FDA Recall Terminated

    Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.

    Recall: Z-2053-2012 · Initiated June 4, 2012

    Recall

    Recall Number
    Z-2053-2012
    Event Number
    62114
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    FSO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 4, 2012
    Posted
    July 20, 2012
    Terminated
    October 29, 2012
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622

    Description

    Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.

    Reason

    Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is used in combination with a remote control connected to a remote video adapter or motorized dual video adapter.

    Action

    Leica Microsystems sent an Urgent Medical Device letter dated June 4, 2012 to the affected customers. The letter described the product, problem and actions to be taken. The customers were informed that the Leica surgical microscope M525 F50 required a software upgrade. Customers were instructed to NOT USE a remote video adapter or motorized video adapter until the required software upgrade has been installed by their Leica Microsystems representative. The customers were requested to complete the attached Acknowledgement Form, acknowledging receipt and understanding of the letter, listing the serial numbers of the units at their facilities and to fax it back to Leica Microsystems at (847) 236-3747.

    Distribution

    Worldwide Distribution - US (nationwide) in the states of: California, Colorado, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, Minnesota, New York, Oklahoma, Oregon, Pennsylvania, Texas, Utah, West Virginia, including Puerto Rico, and the countriy of Canada.

    Quantity

    39 Units - USA , 4 Units - Canada