BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1247-2025 · Reported March 5, 2025

    Enforcement

    Recall Number
    Z-1247-2025
    Event ID
    96220
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 5, 2025
    Initiation Date
    January 30, 2025
    Classification Date
    February 27, 2025
    Address
    Heidelberger Str. 17-19, N/A, Nussloch, N/A, N/A, Germany

    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.

    Code Info

    Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854

    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