BEUDAMED
    FDA Enforcement Class II Terminated

    Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.

    Recall: Z-1744-2013 · Reported July 24, 2013

    Enforcement

    Recall Number
    Z-1744-2013
    Event ID
    65355
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zeiss, Carl Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 24, 2013
    Initiation Date
    May 28, 2013
    Classification Date
    July 17, 2013
    Termination Date
    October 29, 2014
    Address
    1 Zeiss Dr, N/A, Thornwood, NY, 10594-1939, United States

    Description

    Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.

    Reason

    Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager, Axio Scope.A1, Axio Lab.A1) due to Misaligned Full-Wave (Lambda) Plate.

    Code Info

    Model # 445226-0000-000

    Distribution

    Distributed in the states of MI, TX, SD, FL, GA, NY, and NY.

    Quantity

    10