BEUDAMED
    FDA Recall Terminated

    Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.

    Recall: Z-1042-2012 · Initiated December 21, 2011

    Recall

    Recall Number
    Z-1042-2012
    Event Number
    60866
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    ETP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 21, 2011
    Posted
    February 16, 2012
    Terminated
    February 16, 2012
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622

    Description

    Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland The intended use of the microscope is for improving the 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 received complaints stating that the zoom function of the Leica M822 surgical microscope locked up during use.

    Action

    The firm, Leica Microsystems, Inc., sent a "Medical Device Correction" notice dated December 21, 2011 to all affected customers by e-mail. The product, problem, and actions to be taken by the customers were addressed. Customers were instructed- DO NOT USE use the affected product until the software could be upgraded and complete and return the Acknowledgement Form via fax to: 1-847-607-3147 or Scan and send to [email protected]. Leica Microsystems representatives will contact the customers to make necessary arrangements to complete the software upgrade. If you have any questions, contact Director, Global Product Quality Management at 1-847-317-7209.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: California, Colorado, Illinois, New York, Oregon, South Carolina; and countries of: Australia, Japan, Korea, Pakistan, Romania, South Africa, Switzerland and Turkey.

    Quantity

    29 units (10 units-USA)