Leica Microsystems, Inc.: Leica Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and M720; There are three cable connection footswitch models : a) MFS11, stock number 10445599, a 6 function footswitch type B with cross pedals; b) MFS12, stock number 10445600, a 12 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed; c) MFS18, stock number 10448164, a 16 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed;

Recall number

Z-1632-2010

Recalling firm

Leica Microsystems, Inc.

Product

Leica Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and M720; There are three cable connection footswitch models : a) MFS11, stock number 10445599, a 6 function footswitch type B with cross pedals; b) MFS12, stock number 10445600, a 12 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed; c) MFS18, stock number 10448164, a 16 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed;

Status

Terminated

Initiated

2010-03-29

Posted

2010-05-20

Terminated

2011-02-15

Reason

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

Root 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

54 units (52 - U.S., 2 - Canada)

Distribution

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

Lot, serial or model codes

stock number 10445599, serial numbers 90909001 and 301109002;  stock number 10445600, serial numbers 91009001, 81209001, 80909001, 8011001, 71009002, 71009001, 70110002, 61009002, 41209004, 41209002, 291009004, 271009004, 261109001, 250909001, 230909001, 211209005, 211209004, 211009004, 180909002, 180909001, 180110002, 171209002, 161209002, 160909001, 151209001, 140110001, 121009001, 120110002, 120110001, 111209002, 111209001, 110909003, 110909002, 110909001, 11009003, 101209003, 101209002, 101109002 and 100909001; stock number 10448164, serial numbers 80909001, 71209001, 70909002, 31209004, 31209003, 31209002, 31209001, 301009001, 300909001, 291009001, 290909002, 290909001, 240909002, 240909001, 230909001, 180909005, 180909004, 160909002, 100909002 and 100909001;

510(k) numbers

not on file

PMA numbers

not on file

Product code

FSO

Firm FEI

3000210133

Firm city

Bannockburn

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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