LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmwar…

Recall date

January 30, 2025

Source

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

Recall number

Z-1247-2025

FDA classification

Class II

Brand / firm

LEICA BIOSYSTEMS NUSSLOCH GMBH

Sold / distributed

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.

Why it was recalled

Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.

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

What was recalled

Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01