FDA recall Z-1247-2025

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2025-01-30

Report date

2025-03-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nussloch, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1247-2025