BEUDAMED
    FDA Enforcement Class II Terminated

    Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope

    Recall: Z-2441-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2441-2018
    Event ID
    80418
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zeiss, Carl Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    May 29, 2018
    Classification Date
    July 19, 2018
    Termination Date
    July 26, 2024
    Address
    1 Zeiss Dr, Thornwood, NY, 10594-1939, United States

    Description

    Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope

    Reason

    Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate outside of the Celldiscoverer 7 housing. This may result in exposure of the users to harmful UV radiation.

    Code Info

    432332-9020-000

    Distribution

    US Nationwide Distribution

    Quantity

    8