Z-1633-2010

Leica Wireless Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620...

Name: Z-1633-2010 Leica Wireless Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620...
Creator: Leica Microsystems, Inc.
Published: 2010-03-29
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2010-03-29 / Terminated

FDA source

Leica Microsystems, Inc. began a recall of 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)... on 2010-03-29. The reason FDA records is "The pedals of the Footswitch Type B stick and the Zoom/Focus moves to the end position". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1633-2010
Status: Terminated
Initiated: 2010-03-29
Posted: 2010-05-20
Terminated: 2011-02-15
Recalling firm: Leica Microsystems, Inc.
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;
Product code: FSO Microscope, Surgical, General & Plastic Surgery
Reason for recall: The pedals of the Footswitch Type B stick and the Zoom/Focus moves to the end position.
FDA 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 in commerce: 3 units
Distribution: Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia
Product codes and lots: stock number 10448406, serial numbers 60110005, 60110004, 60110003, 60110002, 60110001, 50110001 and 120110001; stock number 10448407, serial numbers 80110003 and 221209001

Product code FSO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)