FDA Recall: Software Issue After Update Possibly Resulting in Loss of Patient Tissue

Company: LEICA BIOSYSTEMS NUSSLOCH GMBH
Date of Enforcement Report: 2/27/2025
Class II

PRODUCT

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

Recall Number:

Z-1247-2025

REASON:

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

RECALLING FIRM/MANUFACTURER:

LEICA BIOSYSTEMS NUSSLOCH GMBH

VOLUME OF PRODUCT IN COMMERCE:

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.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Software Issue After Update Possibly Resulting in Loss of Patient Tissue

Allison Pate

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