FDA-Device2025-03-05Class II
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
LEICA BIOSYSTEMS NUSSLOCH GMBH
Hazard
Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
Sold states
Worldwide - US Nationwide distribution in the states of Idaho and Ohio. The countries of France, Australia, Belgium, China, Germany, Spain, UK, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, Singapore.
Affected count
2
Manufactured in
Heidelberger Str. 17-19, N/A, Nussloch, N/A, Germany
Products
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1247-2025Don't want to check this manually?
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