BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1247-2025 · Initiated January 30, 2025

    Recall

    Recall Number
    Z-1247-2025
    Event Number
    96220
    Firm
    LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany
    FEI Number
    3002179321
    Product Code
    IDP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 30, 2025
    Posted
    February 27, 2025

    Description

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

    Reason

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

    Action

    On January 30, 2025, the firm notified customers through Email of the recall. Customers were provided with immediate actions to take to mitigate the risk of damaging the tissue sample. Among the firm's recommendations was to have a backup instrument if available. The firm's Service organization will contact customers in the coming weeks to organize the upgrade of affected instruments.

    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.

    Quantity

    2