Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and c

FDA device recall Z-2176-2013 · posted 2013-09-10 · Terminated

Recall details

Recalling firm

Leica Microsystems (Schweiz) Ag

Reason for recall

The brake in the Z axis and/or brakes in the AB and C axes failed during installation.

Action taken

The firm, Leica Microsystems, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to DISCONTINUE USE until your system software is updated and to complete and return the attached Acknowledgement Form via email at LMGRA@leica-microsystems.com or fax to: 847-236-3747 or +41 71 726 32 49 within 10 working days after receipt of field safety notice. Your Leica Mycrosystems will contact you to make the necessary arrangements to complete an upgrade at no charge to the customers. If you have any further questions, contact Regulatory Affairs/Quality Assurance Manager at 847-405-5413 or +41 71 726 32 16.

Root cause

Device Design

Status

Terminated

Product code

FSO

Quantity affected

5 units

Distribution

Worldwide distribution: USA (Nationwide) including states of: AK, CA, CO, NY, and OR; and countries of: Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey,

Date initiated

2012-12-18

Date posted

2013-09-10

Date terminated

2017-04-24

Location

Heerbrugg, Switzerland