Class 2 Device Recall Leica Wireless Footswitch, Type B

• Date Initiated by Firm: March 29, 2010
• Date Posted: May 20, 2010
• Recall Status: Terminated on February 15, 2011
• Recall Number: Z-1633-2010
• Recall Event ID: 55241
• Product Classification: surgical microscope footswitch - Product Code FSO
• Product: 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
• Code Information: stock number 10448406, serial numbers 60110005, 60110004, 60110003, 60110002, 60110001, 50110001 and 120110001; stock number 10448407, serial numbers 80110003 and 221209001
• Recalling Firm/ Manufacturer: Leica Microsystems, Inc.; 2345 Waukegan Rd; Bannockburn IL 60015-1515
• For Additional Information Contact: Ms. Elizabeth Culotta; 847-405-6565
• Manufacturer Reason for Recall: The pedals of the Footswitch Type B stick and the Zoom/Focus moves to the end position.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 3 units
• Distribution: Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.