Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component of the Leica M820 C1

FDA device recall Z-1269-2012 · posted 2012-03-21 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

The screws, which lock the bottom plate to the spindle, pull through allowing the carrier arm with touch panel/control unit of the surgical microscope to disconnect, which potentially could result in them falling.

Action taken

The firm, Leica Microsystems, sent a "Medical Device Correction" letter dated February 27, 2012 to the affected customers via e-mail on the same date. The letter described the product, problem and action to be taken. The customers were informed that the Leica M820 and M844 C19 surgical microscopes require upgrading. An upgrade kit will be provide for replacement of the flange and axis of the touch panel/control unit carrier. The Customers were instructed to NOT USE the affected Leica surgical microscope until the unit has been upgraded by their Leica Microsystems representative and to complete the attached Acknowledgement Form, acknowledging the receipt and understanding of the letter, listing the serial numbers of the unit at their facility and fax it back to Leica at 1-847-236-3747. If they have any questions, contact Director, Global Product Quality Management at 1-847-317-7209.

Root cause

Device Design

Status

Terminated

Product code

FSO

Quantity affected

33 units

Distribution

Worldwide distribution: USA (nationwide) including states of: California, Connecticut, Kansas, Missouri, New York, North Dakota, Ohio, Pennsylvania, Texas and Utah; and countries of: Japan and South A

Date initiated

2012-02-27

Date posted

2012-03-21

Date terminated

2012-05-18

Location

Buffalo Grove, IL