BEUDAMED
    FDA Recall Terminated

    Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component of the Leica M820 C19 Surgical Microscope, article 10448196, and the Leica M844 C19 Surgical Microscope, article 10448197; ceiling mounted surgical microscopes; 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-1269-2012 · Initiated February 27, 2012

    Recall

    Recall Number
    Z-1269-2012
    Event Number
    61294
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    FSO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 27, 2012
    Posted
    March 21, 2012
    Terminated
    May 18, 2012
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622

    Description

    Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component of the Leica M820 C19 Surgical Microscope, article 10448196, and the Leica M844 C19 Surgical Microscope, article 10448197; ceiling mounted surgical microscopes; 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

    The screws, which lock the bottom plate to the spindle, pull through allowing the carrier arm with touch panel/control unit of the surgical microscope to disconnect, which potentially could result in them falling.

    Action

    The firm, Leica Microsystems, sent a "Medical Device Correction" letter dated February 27, 2012 to the affected customers via e-mail on the same date. The letter described the product, problem and action to be taken. The customers were informed that the Leica M820 and M844 C19 surgical microscopes require upgrading. An upgrade kit will be provide for replacement of the flange and axis of the touch panel/control unit carrier. The Customers were instructed to NOT USE the affected Leica surgical microscope until the unit has been upgraded by their Leica Microsystems representative and to complete the attached Acknowledgement Form, acknowledging the receipt and understanding of the letter, listing the serial numbers of the unit at their facility and fax it back to Leica at 1-847-236-3747. If they have any questions, contact Director, Global Product Quality Management at 1-847-317-7209.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: California, Connecticut, Kansas, Missouri, New York, North Dakota, Ohio, Pennsylvania, Texas and Utah; and countries of: Japan and South Africa,

    Quantity

    33 units