Leica Wireless Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and

FDA device recall Z-1633-2010 · posted 2010-05-20 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FSO

Quantity affected

3 units

Distribution

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

Date initiated

2010-03-29

Date posted

2010-05-20

Date terminated

2011-02-15

Location

Bannockburn, IL