BEUDAMED
    FDA Recall Terminated

    Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The Laser-TIRF Imaging-System is a Class 3B laser system. The Laser TIRF Imaging System allows the visualization of substances or molecules being capable of fluorescing (excitable by light) by means of an electromagnetic (evanescent) field produced by total internal reflection.

    Recall: Z-1128-2012 · Initiated April 28, 2011

    Recall

    Recall Number
    Z-1128-2012
    Event Number
    59285
    Firm
    Zeiss, Carl Inc
    FEI Number
    2431026
    Product Code
    REK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 28, 2011
    Posted
    February 29, 2012
    Terminated
    December 11, 2012
    Address
    1 Zeiss Dr, Thornwood, NY, 10594-1939

    Description

    Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The Laser-TIRF Imaging-System is a Class 3B laser system. The Laser TIRF Imaging System allows the visualization of substances or molecules being capable of fluorescing (excitable by light) by means of an electromagnetic (evanescent) field produced by total internal reflection.

    Reason

    The manufacturer confirmed that the opto-semiconductor sensors can be triggered by exposure to incandescent lighting. The safety interlock is in place to prevent unintended exposure to Class 3B laser radiation.

    Action

    Carl Zeiss MicroImaging LLC, through trained personnel, first visited each user site, provided additional user instructions, re-labeled the components to provide adequate instruction and warning and further placed a label over the access to the locking screw which secures the component to the microscope. Carl Zeiss Inc. issued "IMPORTANT LASER SAFETY NOTICE: URGENT: FIELD CORRECTIVE ACTION" notices to each user by express courier in late April 2011, Carl Zeiss personnel will confirm that the relabeling has been performed and updated instructions for use have been provided. For questions, please contact the company. The firm will implement 2 actions. Service Representatives will visit each user site, provide additional user instructions, relabel the components to provide adequate instruction and warning, and add a label over the access to the locking screw which secures the component to the microscope. Secondly, when new replacement sensors are available, Carl Zeiss field service technicians will perform the component replacements. Modified components are anticipated to be available within 6 months and replacement completed by April 2012.

    Distribution

    Worldwide Distribution -- USA (nationwide)

    Quantity

    100 units