BEUDAMED
    FDA Recall Terminated

    Leica Wireless Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and M720; There are two wireless models: a) MFS20, stock number 10448406, a 12 function wireless footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed; b) MFS21, stock number 10448407, a 16 function wireless footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed;

    Recall: Z-1633-2010 · Initiated March 29, 2010

    Recall

    Recall Number
    Z-1633-2010
    Event Number
    55241
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    FSO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 29, 2010
    Posted
    May 20, 2010
    Terminated
    February 15, 2011
    Address
    2345 Waukegan Rd, Bannockburn, IL, 60015-1515

    Description

    Leica Wireless Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and M720; There are two wireless models: a) MFS20, stock number 10448406, a 12 function wireless footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed; b) MFS21, stock number 10448407, a 16 function wireless footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed;

    Reason

    The pedals of the Footswitch Type B stick and the Zoom/Focus moves to the end position.

    Action

    Leica Microsystems sent Medical Device Correction letters dated 3/29/10 to the affected customers via first class mail on the same date, informing them of the potential for injury to the patient's eye if the cross pedal of the footswitch sticks. They were informed that their local Leica Microsystems representative will contact them to arrange for the replacement of the cross pedal. The letters also provided the interim necessary steps required to avoid the risk of patient injury while they are awaiting the cross pedal replacement, i.e. do not use the affected footswitches with a surgical microscope that has a BIOM accessory. The accounts were requested to complete the attached Acknowledgement Form, listing the serial numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. A company contact was provided in the letter for questions.

    Distribution

    Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia

    Quantity

    3 units