Leica Microsystems, Inc. recalls Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 1044…

Recall date

June 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2555-2018

FDA classification

Class II

Brand / firm

Leica Microsystems, Inc.

Sold / distributed

Worldwide Distribution US Nationwide in the states of : CA, CO, CT, FL, HI, ID, IL, KS, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SD, TN, TX. International Distribution: Canada, AUSTRALIA, BELGIUM, Bolivia, BRAZIL, BULGARIA, CHILE, CHINA, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HON…

Why it was recalled

Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied for observation and documentation and for human and veterinary medical treatment. Not for use in Eye Operations.