Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component

FDA device recall Z-1042-2012 · posted 2012-02-16 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

Leica Microsystems received complaints stating that the zoom function of the Leica M822 surgical microscope locked up during use.

Action taken

The firm, Leica Microsystems, Inc., sent a "Medical Device Correction" notice dated December 21, 2011 to all affected customers by e-mail. The product, problem, and actions to be taken by the customers were addressed. Customers were instructed- DO NOT USE use the affected product until the software could be upgraded and complete and return the Acknowledgement Form via fax to: 1-847-607-3147 or Scan and send to elizabeth.culotta@leica-microsystems.com. Leica Microsystems representatives will contact the customers to make necessary arrangements to complete the software upgrade. If you have any questions, contact Director, Global Product Quality Management at 1-847-317-7209.

Root cause

Device Design

Status

Terminated

Product code

ETP

Quantity affected

29 units (10 units-USA)

Distribution

Worldwide distribution: USA (nationwide) including states of: California, Colorado, Illinois, New York, Oregon, South Carolina; and countries of: Australia, Japan, Korea, Pakistan, Romania, South Afri

Date initiated

2011-12-21

Date posted

2012-02-16

Date terminated

2012-02-16

Location

Buffalo Grove, IL