FDA recall Z-2659-2018

Leica Microsystems, Inc. · Class II · device

Product

Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.

Reason for recall

Recall is due to a design weakness of the power insert module.

Distribution

United States distribution: AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, KY, LA, MO, NJ, NY, NV, OH, OR, PA, TX, UT, PR. International distribution to Japan, Brazil, Columbia, Ecuador, Mexico, Taiwan

Key facts

Status
Terminated
Initiation date
2018-06-25
Report date
2018-08-15
Termination date
2019-02-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Buffalo Grove, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2659-2018