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Leica Microsystems, Inc. recalls Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448
Recalled August 1, 2018 · FDA recall Z-2555-2018 · Leica Microsystems
Hazard
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. · FDA Class II
Units
8,564 Total Units
Sold at
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, HONGKONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, MALAYSIA, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, TAIWAN,THAILAND, TURKEY, UK
Description
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.
Product
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.
Manufacturer(s)
Leica Microsystems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →