BEUDAMED
    FDA Enforcement Class II Terminated

    Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research.

    Recall: Z-2058-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2058-2018
    Event ID
    80115
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zeiss, Carl Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    May 8, 2018
    Classification Date
    July 11, 2018
    Termination Date
    April 21, 2020
    Address
    1 Zeiss Dr, N/A, Thornwood, NY, 10594-1939, United States

    Description

    Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research.

    Reason

    In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.

    Code Info

    Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes

    Distribution

    USA (nationwide)

    Quantity

    1070 units to US