BEUDAMED
    FDA Enforcement Class II Terminated

    Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)

    Recall: Z-1629-2020 · Reported April 15, 2020

    Enforcement

    Recall Number
    Z-1629-2020
    Event ID
    84163
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zeiss, Carl Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    April 15, 2020
    Initiation Date
    October 2, 2019
    Classification Date
    April 6, 2020
    Termination Date
    July 25, 2024
    Address
    1 Zeiss Dr, N/A, Thornwood, NY, 10594-1939, United States

    Description

    Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)

    Reason

    When the user tilts the transmitted light arm of the microscope to the end of its axis range, laser safety can be bypassed and result in emission of class lIlb laser radiation. This issue arises when a ZEISS inverted stage stand (Axio Observer or Axio Vert) is used in as a component of the LSM 700, 800 and 900 system

    Code Info

    (LSM 700, LSM 800 and LSM 900)

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    US: 600; Global: 1600