BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2441-2018 · Initiated May 29, 2018

    Recall

    Recall Number
    Z-2441-2018
    Event Number
    80418
    Firm
    Zeiss, Carl Inc
    FEI Number
    2431026
    Product Code
    RGW
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    May 29, 2018
    Terminated
    July 26, 2024
    Address
    1 Zeiss Dr, Thornwood, NY, 10594-1939

    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.

    Action

    The Company will immediately notify by direct contact (when available) and/or express courier each first line purchaser and/or known user site with informing them of the risk, how to prevent it and the notice of action. The Company will dispatch factory trained service representatives to perform following actions: o Installation of Hot Fix # 14 (or newer) for ZEN 2.3 o Installation of Firmware 1 .209 (or newer) on nodes x l 5 and x l 9 (Main Controller 2)

    Distribution

    US Nationwide Distribution

    Quantity

    8